It is Tammy Haut-Donahue 's quest to rid the world of osteoarthritis, which afflicts 20 million Americans. Some suffer from injury; others from the wear and tear of age.
The condition results from the degeneration of the cartilage in joints, the most troublesome being the knee. When cartilage is worn away, a painful rubbing of bone on bone occurs.
Haut-Donahue, a mechanical engineer at Michigan Technological University, believes the cure for osteoarthritis will begin with the meniscus, a little-understood buffer between the two major leg bones the femur and the tibia that meet in the knee. She endeavors to unravel its mysteries.
Artificial replacements for damaged tissue are not effective. Neither is the removal of damaged tissue. Rather, she investigates tissue engineering so the meniscus can be repaired or replaced following damage.
The science isn't there yet. "To repair the meniscus, we have to understand how the old one works."
Her inquiry, which ranges from computer modeling to working with animals, could revolutionize medicine. Most of the research in the US, she says, addresses what happens to bone and cartilage in the absence of meniscus; she wants to protect the cartilage. "Then you won't have the arthritis problem in the first place."
Michigan Technological University is a leading public research university, conducting research, developing new technologies and preparing students to create the future for a prosperous and sustainable world. Michigan Tech offers more than 130 undergraduate and graduate degree programs in engineering, forestry and environmental sciences, computing, technology, business and economics, natural and physical sciences, arts, humanities and social sciences.
Source: Michigan Technological University
суббота, 30 апреля 2011 г.
пятница, 29 апреля 2011 г.
IlluminOss Announces First Human Case Utilizing Its Innovative Photodynamic Bone Stabilization System Technology
IlluminOss Medical Inc., a medical device company developing the innovative IlluminOss(TM) Photodynamic Bone Stabilization System for orthopedic surgery, announced that the first procedure utilizing the IlluminOss Photodynamic Bone Stabilization System had been performed on a 21 year old patient with a fracture of the 5th metacarpal.
With traditional methods of treating fractures, often an incision the full length of the fracture line has to be made; and plates and screws inserted to stabilize the fracture. There may be extensive soft tissue damage; the patient has limited or no mobility initially which may lead to temporary or permanent stiffness; and the patient may experience severe pain.
The IlluminOss Photodynamic Bone Stabilization System requires just a small 4.5mm pathway into the bone to stabilize it. A small diameter balloon catheter and light fiber are inserted into the intramedullary canal of the bone. A photo sensitive, liquid monomer is then infused into the balloon. The monomer expands the balloon to fit the contours of the interior of the bone, aiding in the reduction of the fracture. Then the light source is activated, converting the liquid monomer into a hardened polymer within 90 seconds. The tiny skin incision is then closed.
Unlike other methods of fracture treatment, the IlluminOss Photodynamic Bone Stabilization System is designed to enable the patient to have immediate joint mobility post procedure without the need for immobilization. The fracture also becomes partially weight bearing immediately. Due to the minimally invasive approach, soft tissue injury is virtually eliminated. Having immediate mobility minimizes the potential for tendon adhesions and a tenolysis procedure to remove them.
According to Arnold-Peter C. Weiss, M.D., Chief Medical Officer of IlluminOss Medical, "The instrumentation is intuitive and easy to use. The case report from the hospital indicates that the overall procedure went according to plan with no complications. The patient had mobility immediately. At six weeks the x-rays showed an advanced consolidation process, with no migration of the device and no displacement of the fracture. Clinically, the patient had complete mobility and almost the same strength with a minimal scar. He was working and leading a normal life."
Said Bob Rabiner, Founder and CEO of IlluminOss Medical, "This case represents a major milestone for IlluminOss and patients worldwide. We believe that our minimally invasive technology will fundamentally improve the treatment of hundreds of thousands of bone fractures by driving much earlier restoration of functionality, improving the durability of orthopedic repairs, decreasing pain and reducing scarring."
About IlluminOss Medical Inc.
IlluminOss Medical is a privately held, early-stage medical device company dedicated to the development of minimally invasive orthopedic systems for the stabilization and treatment of bone fractures. The IlluminOss Photodynamic Bone Stabilization System utilizes a photodynamic (light-curable) polymer system intended to eliminate the need for traditional, inconvenient and painful methods of bone fixation with external pins, plates and screws. The Company is currently developing the IlluminOss Photodynamic Bone Stabilization System for small bones such as fractures of the hands, wrists, clavicle and arms. It is anticipated that the IlluminOss Photodynamic Bone Stabilization System will also have applications in the spine and long bones.
Founded in 2007, IlluminOss is headquartered in East Providence, RI. For more information about IlluminOss Medical, please visit illuminoss.
IlluminOss Medical Inc.
illuminoss
View drug information on Photodynamic Therapy.
With traditional methods of treating fractures, often an incision the full length of the fracture line has to be made; and plates and screws inserted to stabilize the fracture. There may be extensive soft tissue damage; the patient has limited or no mobility initially which may lead to temporary or permanent stiffness; and the patient may experience severe pain.
The IlluminOss Photodynamic Bone Stabilization System requires just a small 4.5mm pathway into the bone to stabilize it. A small diameter balloon catheter and light fiber are inserted into the intramedullary canal of the bone. A photo sensitive, liquid monomer is then infused into the balloon. The monomer expands the balloon to fit the contours of the interior of the bone, aiding in the reduction of the fracture. Then the light source is activated, converting the liquid monomer into a hardened polymer within 90 seconds. The tiny skin incision is then closed.
Unlike other methods of fracture treatment, the IlluminOss Photodynamic Bone Stabilization System is designed to enable the patient to have immediate joint mobility post procedure without the need for immobilization. The fracture also becomes partially weight bearing immediately. Due to the minimally invasive approach, soft tissue injury is virtually eliminated. Having immediate mobility minimizes the potential for tendon adhesions and a tenolysis procedure to remove them.
According to Arnold-Peter C. Weiss, M.D., Chief Medical Officer of IlluminOss Medical, "The instrumentation is intuitive and easy to use. The case report from the hospital indicates that the overall procedure went according to plan with no complications. The patient had mobility immediately. At six weeks the x-rays showed an advanced consolidation process, with no migration of the device and no displacement of the fracture. Clinically, the patient had complete mobility and almost the same strength with a minimal scar. He was working and leading a normal life."
Said Bob Rabiner, Founder and CEO of IlluminOss Medical, "This case represents a major milestone for IlluminOss and patients worldwide. We believe that our minimally invasive technology will fundamentally improve the treatment of hundreds of thousands of bone fractures by driving much earlier restoration of functionality, improving the durability of orthopedic repairs, decreasing pain and reducing scarring."
About IlluminOss Medical Inc.
IlluminOss Medical is a privately held, early-stage medical device company dedicated to the development of minimally invasive orthopedic systems for the stabilization and treatment of bone fractures. The IlluminOss Photodynamic Bone Stabilization System utilizes a photodynamic (light-curable) polymer system intended to eliminate the need for traditional, inconvenient and painful methods of bone fixation with external pins, plates and screws. The Company is currently developing the IlluminOss Photodynamic Bone Stabilization System for small bones such as fractures of the hands, wrists, clavicle and arms. It is anticipated that the IlluminOss Photodynamic Bone Stabilization System will also have applications in the spine and long bones.
Founded in 2007, IlluminOss is headquartered in East Providence, RI. For more information about IlluminOss Medical, please visit illuminoss.
IlluminOss Medical Inc.
illuminoss
View drug information on Photodynamic Therapy.
четверг, 28 апреля 2011 г.
As Former President George Bush Recuperates From Hip Replacement Surgery, Physical Therapy Will Play Key Role In Recovery
As former President
George H. W. Bush recovers from last week's surgery at the Mayo Clinic to
replace his right hip, periodic and progressive physical therapy will play
a key role in his successful rehabilitation, says the American Physical
Therapy Association (APTA).
"Following hip replacement surgery, physical therapy is routinely used,
either in a home health, out-patient, or a rehabilitation setting," says
Dale Avers, PT, DPT, PhD, a professor in physical therapy at SUNY Upstate
Medical University in Syracuse, NY. Avers, who has been conducting research
regarding exercise for aging adults, including those with hip replacements,
warns that residual weakness, which can include balance impairment, may
become evident even years following hip replacement surgery if not properly
addressed.
"Physical therapy, not necessarily on a continuous basis, is now
recommended for patients with hip replacements," says Avers. "Starting
around 4 months, physical therapy, which includes strength training,
mobility and balance exercises, is recommended for optimal results."
The leading indicator for hip replacement is pain and impaired
mobility, not age, notes Avers, very often associated with osteoarthritis.
Physical therapists can improve mobility and decrease pain through manual
therapy and strengthening exercises. Hip replacement surgery is recommended
as a last resort, when the pain becomes unbearable and interferes with
mobility.
For President Bush, Senator Elizabeth Dole, and other patients with hip
replacements, physical therapy starts immediately in the hospital following
surgery, beginning with gentle mobility exercises and activities, says
Avers. Gradually, the exercises are progressed as healing takes place.
Avers said that once the immediate post-op rehabilitation is complete,
patients should return to physical therapy for continued strength and
balance training. "As healing progresses, they need the guidance of a
physical therapist to achieve optimal results and to return to full
function in the activities they enjoy," Avers said.
"Successful hip replacement surgery is the first step in President
Bush's recovery and to enjoying his normal activities," says Avers.
"Physical therapy is the finishing touch."
The American Physical Therapy Association (apta) is a
national organization representing nearly 70,000 physical therapists,
physical therapist assistants, and students nationwide. Its goal is to
foster advancements in physical therapist education, practice, and
research. Consumers can access "Find a PT" to find a physical therapist in
their area, as well as other physical therapy news and information at
apta/consumer.
American Physical Therapy Association
apta
George H. W. Bush recovers from last week's surgery at the Mayo Clinic to
replace his right hip, periodic and progressive physical therapy will play
a key role in his successful rehabilitation, says the American Physical
Therapy Association (APTA).
"Following hip replacement surgery, physical therapy is routinely used,
either in a home health, out-patient, or a rehabilitation setting," says
Dale Avers, PT, DPT, PhD, a professor in physical therapy at SUNY Upstate
Medical University in Syracuse, NY. Avers, who has been conducting research
regarding exercise for aging adults, including those with hip replacements,
warns that residual weakness, which can include balance impairment, may
become evident even years following hip replacement surgery if not properly
addressed.
"Physical therapy, not necessarily on a continuous basis, is now
recommended for patients with hip replacements," says Avers. "Starting
around 4 months, physical therapy, which includes strength training,
mobility and balance exercises, is recommended for optimal results."
The leading indicator for hip replacement is pain and impaired
mobility, not age, notes Avers, very often associated with osteoarthritis.
Physical therapists can improve mobility and decrease pain through manual
therapy and strengthening exercises. Hip replacement surgery is recommended
as a last resort, when the pain becomes unbearable and interferes with
mobility.
For President Bush, Senator Elizabeth Dole, and other patients with hip
replacements, physical therapy starts immediately in the hospital following
surgery, beginning with gentle mobility exercises and activities, says
Avers. Gradually, the exercises are progressed as healing takes place.
Avers said that once the immediate post-op rehabilitation is complete,
patients should return to physical therapy for continued strength and
balance training. "As healing progresses, they need the guidance of a
physical therapist to achieve optimal results and to return to full
function in the activities they enjoy," Avers said.
"Successful hip replacement surgery is the first step in President
Bush's recovery and to enjoying his normal activities," says Avers.
"Physical therapy is the finishing touch."
The American Physical Therapy Association (apta) is a
national organization representing nearly 70,000 physical therapists,
physical therapist assistants, and students nationwide. Its goal is to
foster advancements in physical therapist education, practice, and
research. Consumers can access "Find a PT" to find a physical therapist in
their area, as well as other physical therapy news and information at
apta/consumer.
American Physical Therapy Association
apta
среда, 27 апреля 2011 г.
Spine Institute Of Louisiana Offers Cervical Spine Motion Preservation As An Alternative To Fusion Surgery
The Spine Institute of
Louisiana, in conjunction with SpineMark Corporation, is now offering
cervical spine motion preservation procedures as an alternative to the
traditional fusion surgery typically used for cervical spine damage. To
provide patients with alternative surgical options, Spine Institute of
Louisiana is now enrolling patients in several clinical trials using motion
preservation spinal devices aimed at maintaining natural movement. As part
of this initiative, Dr. Pierce Nunley, medical director of the institute,
recently performed the first ever two-level total disc replacement of the
neck in the state of Louisiana.
Spinal fusion has been the standard surgical care for numerous spine
conditions such as scoliosis, degenerative disc disease, instability of the
spine or spinal fractures. Unlike spinal fusion, which achieves pain relief
through immobilization, artificial discs maintain motion at the operative
level once the damaged disc has been removed. Furthermore, artificial disc
replacements provide a more rapid return to activity than fusion surgery,
which requires time for the bone graft to grow into a solid mass for
stabilization.
One such motion preservation trial involving patients with degenerative
disc disease of the cervical spine, commonly known as a herniated, ruptured
or slipped disc, involves the replacement of the diseased disc with an
artificial disc. In a special case that qualified for treatment within the
study, Dr. Nunley conducted a two-level replacement -- a procedure that
replaces two damaged discs sitting atop one another -- the first ever in
the state of Louisiana. The beneficiary of this investigational procedure
is Darrel Betha, a 46-year-old hurricane Katrina evacuee who had been
suffering from neck and arm pain since 2004 following a work-place
accident, and is now living pain free.
"At one point in time, I couldn't lift my right arm without pain and
numbness in my arm, neck, shoulder and back," said Darrell Betha. "Now, I
don't feel the pain."
Betha, a welder of twelve years prior to suffering an injury on the job
in 2004 and has been out of work since, is looking forward to a speedy
recovery and a return to work.
"Motion preservation procedures provide patients with an opportunity to
evaluate various treatment options to address their neck and spine
problems," said Dr. Pierce D. Nunley, of the Spine Institute of Louisiana.
"We are thrilled to be able to offer these cutting edge procedures to
patients at our facility. It allows us to find the treatment option that
best fits each individual patient, and we are able to successfully treat
the majority of our patients with conservative treatment modalities and
identify those patients who truly need surgery."
"While fusions continue to be the standard, motion preservation is at
the forefront of advances in spine care," said Marcy Rogers, president and
CEO of SpineMark Corporation. "We value the opportunity to participate in
trials that could lead to additional treatment options for patients in
search of a therapy that is right for them."
SpineMark Corporation, headquartered in San Diego, manages a network of
clinical trial sites across the country specializing in spine and back
treatment, and played an integral role in bringing this clinical study to
the Spine Institute of Louisiana.
About the Spine Institute of Louisiana
Spine Institute of Louisiana is dedicated to the non-operative and
operative treatment of various disorders of the spine. The physicians at
the institute specialize in treating both simple and complex neck and back
problems.
About SpineMark
SpineMark Corporation, headquartered in San Diego, combines the
clinical, business development, contracting, marketing and research
expertise to establish Spine Centers of Excellence. Formed as a joint
venture between Texas Back Institute Holdings and Management Technology
Resources, the two entities are dedicated to unite all of the necessary
experience and expertise under the management of recognized leaders in both
the business and medical world of spine care. To learn more about SpineMark
visit: spinemark.
SpineMark Corporation
spinemark
Louisiana, in conjunction with SpineMark Corporation, is now offering
cervical spine motion preservation procedures as an alternative to the
traditional fusion surgery typically used for cervical spine damage. To
provide patients with alternative surgical options, Spine Institute of
Louisiana is now enrolling patients in several clinical trials using motion
preservation spinal devices aimed at maintaining natural movement. As part
of this initiative, Dr. Pierce Nunley, medical director of the institute,
recently performed the first ever two-level total disc replacement of the
neck in the state of Louisiana.
Spinal fusion has been the standard surgical care for numerous spine
conditions such as scoliosis, degenerative disc disease, instability of the
spine or spinal fractures. Unlike spinal fusion, which achieves pain relief
through immobilization, artificial discs maintain motion at the operative
level once the damaged disc has been removed. Furthermore, artificial disc
replacements provide a more rapid return to activity than fusion surgery,
which requires time for the bone graft to grow into a solid mass for
stabilization.
One such motion preservation trial involving patients with degenerative
disc disease of the cervical spine, commonly known as a herniated, ruptured
or slipped disc, involves the replacement of the diseased disc with an
artificial disc. In a special case that qualified for treatment within the
study, Dr. Nunley conducted a two-level replacement -- a procedure that
replaces two damaged discs sitting atop one another -- the first ever in
the state of Louisiana. The beneficiary of this investigational procedure
is Darrel Betha, a 46-year-old hurricane Katrina evacuee who had been
suffering from neck and arm pain since 2004 following a work-place
accident, and is now living pain free.
"At one point in time, I couldn't lift my right arm without pain and
numbness in my arm, neck, shoulder and back," said Darrell Betha. "Now, I
don't feel the pain."
Betha, a welder of twelve years prior to suffering an injury on the job
in 2004 and has been out of work since, is looking forward to a speedy
recovery and a return to work.
"Motion preservation procedures provide patients with an opportunity to
evaluate various treatment options to address their neck and spine
problems," said Dr. Pierce D. Nunley, of the Spine Institute of Louisiana.
"We are thrilled to be able to offer these cutting edge procedures to
patients at our facility. It allows us to find the treatment option that
best fits each individual patient, and we are able to successfully treat
the majority of our patients with conservative treatment modalities and
identify those patients who truly need surgery."
"While fusions continue to be the standard, motion preservation is at
the forefront of advances in spine care," said Marcy Rogers, president and
CEO of SpineMark Corporation. "We value the opportunity to participate in
trials that could lead to additional treatment options for patients in
search of a therapy that is right for them."
SpineMark Corporation, headquartered in San Diego, manages a network of
clinical trial sites across the country specializing in spine and back
treatment, and played an integral role in bringing this clinical study to
the Spine Institute of Louisiana.
About the Spine Institute of Louisiana
Spine Institute of Louisiana is dedicated to the non-operative and
operative treatment of various disorders of the spine. The physicians at
the institute specialize in treating both simple and complex neck and back
problems.
About SpineMark
SpineMark Corporation, headquartered in San Diego, combines the
clinical, business development, contracting, marketing and research
expertise to establish Spine Centers of Excellence. Formed as a joint
venture between Texas Back Institute Holdings and Management Technology
Resources, the two entities are dedicated to unite all of the necessary
experience and expertise under the management of recognized leaders in both
the business and medical world of spine care. To learn more about SpineMark
visit: spinemark.
SpineMark Corporation
spinemark
вторник, 26 апреля 2011 г.
Study Shows Fish Oil To Be Safe And Effective For Neck And Back Conditions
Fish oil given to patients with chronic neck and low-back pain has proven to be effective, according to a study published in the April 2006 issue of Surgical Neurology.
The patented fish oil supplement was administered to 250 patients under physician's care, most of whom suffered from degenerative disc conditions.Back problems are "one of the greatest causes of pain and disability in the United States," according to Joseph Maroon, MD, the study's lead author and vice chairman of the Department of Neurological Surgery at the University of Pittsburgh School of Medicine. Maroon's study team chose ProEPA(TM)/EPA(TM) from Nordic Naturals, Inc. ProEPA provides omega-3 essential fatty acids (1,230 mg/2 capsules) with a high concentration of eicosapentanenoic acid (EPA). Patients took 2 or 4 capsules a day.
After beginning supplementation, subjects were given a questionnaire asking for clinical improvements and any side effects. After an average of 75 days of fish oil supplementation, 60% of respondents reported significant improvements, including reduction in overall pain and 59% were able to stop taking other pain medicine. None of the patients experienced significant side effects and 88% of the respondents planned to continue using the fish oil omega-3s.
"It is important for patients to know that safer alternatives to pain medications are available," said Dr. Maroon. "A fish oil supplement containing EPA and DHA omega-3s is an effective choice with fewer or no side effects. People should be careful to choose a pharmaceutical-grade fish oil supplement that is fresh and free of potentially harmful heavy metals, such as the mercury, PCPs, and dioxins that can be found in fish.
"Our study adds to the numerous publications showing the widespread health benefits of fish oil omega-3s. Additional clinical trials, along with ours, now show that patients with chronic joint pain who take an adequate amount of natural purified fish oil, for a long enough period of time, can get meaningful relief without relying on medications," said Dr.Maroon.
Founded by husband-and-wife team Joar and Michele Opheim, Nordic Naturals is the leader in omega-3 fish oils and EFA blends with exceptional taste, freshness, and purity levels. The company offers over 50 different fish oil products and EFA blends, including liquids, capsules, and children's chewables.
Nordic Naturals, Inc.
nordicnaturals
The patented fish oil supplement was administered to 250 patients under physician's care, most of whom suffered from degenerative disc conditions.Back problems are "one of the greatest causes of pain and disability in the United States," according to Joseph Maroon, MD, the study's lead author and vice chairman of the Department of Neurological Surgery at the University of Pittsburgh School of Medicine. Maroon's study team chose ProEPA(TM)/EPA(TM) from Nordic Naturals, Inc. ProEPA provides omega-3 essential fatty acids (1,230 mg/2 capsules) with a high concentration of eicosapentanenoic acid (EPA). Patients took 2 or 4 capsules a day.
After beginning supplementation, subjects were given a questionnaire asking for clinical improvements and any side effects. After an average of 75 days of fish oil supplementation, 60% of respondents reported significant improvements, including reduction in overall pain and 59% were able to stop taking other pain medicine. None of the patients experienced significant side effects and 88% of the respondents planned to continue using the fish oil omega-3s.
"It is important for patients to know that safer alternatives to pain medications are available," said Dr. Maroon. "A fish oil supplement containing EPA and DHA omega-3s is an effective choice with fewer or no side effects. People should be careful to choose a pharmaceutical-grade fish oil supplement that is fresh and free of potentially harmful heavy metals, such as the mercury, PCPs, and dioxins that can be found in fish.
"Our study adds to the numerous publications showing the widespread health benefits of fish oil omega-3s. Additional clinical trials, along with ours, now show that patients with chronic joint pain who take an adequate amount of natural purified fish oil, for a long enough period of time, can get meaningful relief without relying on medications," said Dr.Maroon.
Founded by husband-and-wife team Joar and Michele Opheim, Nordic Naturals is the leader in omega-3 fish oils and EFA blends with exceptional taste, freshness, and purity levels. The company offers over 50 different fish oil products and EFA blends, including liquids, capsules, and children's chewables.
Nordic Naturals, Inc.
nordicnaturals
Genzyme Receives FDA Approval For New Labeling For Carticel(R)
Genzyme Corporation
(Nasdaq: GENZ) announced today that the U. S. Food and Drug Administration
(FDA) has approved new labeling for Carticel(R) (autologous cultured
chondrocytes) based on the completion of a post-approval commitment study.
This label incorporates safety and efficacy data from the Study of the
Treatment of Articular Repair (STAR) as a result of Genzyme's successful
completion of this final confirmatory, post-marketing study.
"Genzyme has pioneered cartilage repair in the field of orthopaedics
and sports medicine for more than a decade," said Ann Merrifield, president
of Genzyme Biosurgery, the division that manufactures and commercializes
Carticel. "Now, the successful completion of our final FDA post-approval
commitment further confirms Carticel's safety and effectiveness for
patients with troublesome and debilitating cartilage injuries in the knee.
Carticel has already benefited thousands of patients with specific types of
cartilage injuries where there traditionally have been limited treatment
options. With this new data on-label, we hope to provide all appropriate
patients access to therapy."
The STAR study investigated the safety and effectiveness of Carticel in
patients who had an inadequate response to a previous cartilage repair
procedure in the knee. Investigators enrolled patients in 29 clinical
centers in this prospective 4-year study, which achieved all of its
endpoints. The data from the STAR study will be presented at the upcoming
American Orthopaedic Society for Sports Medicine (AOSSM) Meeting on Sunday,
July 15, 2007 in Calgary, Canada.
"Carticel has been established as a unique and valuable tool for
orthopaedic surgeons in the treatment of patients with cartilage injuries
in the knee. Accordingly, it is important that all appropriately indicated
patients have access to this technology," said David Levine, M.D., Vice
President, Clinical Research for Genzyme Biosurgery. "Now that the post-
approval commitments have been completed, we are confident that health
plans that had yet to cover this treatment option will adopt the
appropriate medical policy for Carticel."
A Unique Cell Therapy
Carticel is used by orthopaedic surgeons to treat patients who have
clinically significant articular cartilage lesions on the thigh bone part
of the knee caused by acute or repetitive trauma that has not responded to
a prior cartilage repair procedure. Carticel should only be used in
conjunction with debridement, placement of a periosteal flap and
rehabilitation. The independent contributions of the autologous cultured
chondrocytes and other components of the therapy to outcome are unknown.
Carticel employs a unique process to grow a patient's own cartilage cells
for implantation to correct certain types of damage. The treatment starts
when an orthopaedic surgeon trained in the use of Carticel provides Genzyme
with a biopsy of healthy cartilage taken from a patient's knee in an
arthroscopic procedure. Technicians at Genzyme's cell culture laboratory in
Cambridge, MA use proprietary methods to grow millions of cells from this
biopsy. The cells are then delivered to the hospital, where the surgeon
implants them into the patient's knee defect in a surgical procedure.
Carticel was the first cell therapy to be approved by the FDA. First
introduced in March of 1995, Carticel received accelerated approval from
the FDA in August of 1997 after the FDA instituted specific cell therapy
guidelines. Under accelerated approval, the FDA required Genzyme to conduct
confirmatory post-marketing studies.
To learn more about Carticel please visit carticel
Cell Therapy Expertise at Genzyme
Genzyme has more than a decade of experience in developing and
manufacturing autologous cell therapy products that have been used to treat
thousands of patients. Epicel(R) (cultured epidermal autografts), a cell
therapy for treating patients with severe burns, is also manufactured by
Genzyme. Together, Carticel and Epicel represent the first such products
ever brought to market in the United States, providing Genzyme with
superior scientific and commercial expertise in this field.
About Carticel
Carticel is for autologous use and is indicated for the repair of
symptomatic, cartilage defects of the femoral condyle (medial, lateral or
trochlea), caused by acute or repetitive trauma, in patients who have had
an inadequate response to a prior arthroscopic or other surgical repair
procedure (e.g., debridement, microfracture, drilling/abrasion
arthroplasty, or osteochondral allograft/autograft). Carticel should only
be used in conjunction with debridement, placement of a periosteal flap and
rehabilitation. The independent contributions of the autologous cultured
chondrocytes and other components of the therapy to outcome are unknown. It
is not indicated for the treatment of cartilage damage associated with
generalized osteoarthritis. It is not recommended for patients whose knee
meniscus has been surgically removed unless the patient has undergone
surgical reconstruction prior to or concurrent with Carticel implantation.
Pre-existing conditions including meniscal tears, joint instability or
malalignment of the joint should be corrected prior to or concurrent with
Carticel implantation. It should not be used in patients with a known
history of hypersensitivity to gentamicin, other aminoglycosides or
materials of bovine origin. Carticel is not routinely tested for
transmissible infectious diseases and may transmit disease to the
healthcare provider handling Carticel. In addition, it should not be used
in patients who have previously had cancer in the bones, cartilage, fat or
muscle of the treated limb. Use in children, patients over age 65, or in
joints other than the knee has not yet been assessed.
The occurrence of a subsequent surgical procedure, primarily
arthroscopy, following Carticel implantation is common. The most common
reactions (>5% of patients), derived from the Study of the Treatment of
Articular Repair (STAR), include arthrofibrosis/joint adhesions, graft
overgrowth, chondromalacia or chondrosis, cartilage injury, graft
complication, meniscal lesion, graft delamination, and osteoarthritis.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people with
serious diseases. Since 1981, the company has grown from a small start-up
to a diversified enterprise with more than 9,000 employees in locations
spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been
selected by FORTUNE as one of the "100 Best Companies to Work for" in the
United States.
With many established products and services helping patients in nearly
90 countries, Genzyme is a leader in the effort to develop and apply the
most advanced technologies in the life sciences. The company's products and
services are focused on rare inherited disorders, kidney disease,
orthopedics, cancer, transplant, and diagnostic testing. Genzyme's
commitment to innovation continues today with a substantial development
program focused on these fields, as well as immune disease, infectious
disease, and other areas of unmet medical need.
Genzyme Corporation
genzyme
(Nasdaq: GENZ) announced today that the U. S. Food and Drug Administration
(FDA) has approved new labeling for Carticel(R) (autologous cultured
chondrocytes) based on the completion of a post-approval commitment study.
This label incorporates safety and efficacy data from the Study of the
Treatment of Articular Repair (STAR) as a result of Genzyme's successful
completion of this final confirmatory, post-marketing study.
"Genzyme has pioneered cartilage repair in the field of orthopaedics
and sports medicine for more than a decade," said Ann Merrifield, president
of Genzyme Biosurgery, the division that manufactures and commercializes
Carticel. "Now, the successful completion of our final FDA post-approval
commitment further confirms Carticel's safety and effectiveness for
patients with troublesome and debilitating cartilage injuries in the knee.
Carticel has already benefited thousands of patients with specific types of
cartilage injuries where there traditionally have been limited treatment
options. With this new data on-label, we hope to provide all appropriate
patients access to therapy."
The STAR study investigated the safety and effectiveness of Carticel in
patients who had an inadequate response to a previous cartilage repair
procedure in the knee. Investigators enrolled patients in 29 clinical
centers in this prospective 4-year study, which achieved all of its
endpoints. The data from the STAR study will be presented at the upcoming
American Orthopaedic Society for Sports Medicine (AOSSM) Meeting on Sunday,
July 15, 2007 in Calgary, Canada.
"Carticel has been established as a unique and valuable tool for
orthopaedic surgeons in the treatment of patients with cartilage injuries
in the knee. Accordingly, it is important that all appropriately indicated
patients have access to this technology," said David Levine, M.D., Vice
President, Clinical Research for Genzyme Biosurgery. "Now that the post-
approval commitments have been completed, we are confident that health
plans that had yet to cover this treatment option will adopt the
appropriate medical policy for Carticel."
A Unique Cell Therapy
Carticel is used by orthopaedic surgeons to treat patients who have
clinically significant articular cartilage lesions on the thigh bone part
of the knee caused by acute or repetitive trauma that has not responded to
a prior cartilage repair procedure. Carticel should only be used in
conjunction with debridement, placement of a periosteal flap and
rehabilitation. The independent contributions of the autologous cultured
chondrocytes and other components of the therapy to outcome are unknown.
Carticel employs a unique process to grow a patient's own cartilage cells
for implantation to correct certain types of damage. The treatment starts
when an orthopaedic surgeon trained in the use of Carticel provides Genzyme
with a biopsy of healthy cartilage taken from a patient's knee in an
arthroscopic procedure. Technicians at Genzyme's cell culture laboratory in
Cambridge, MA use proprietary methods to grow millions of cells from this
biopsy. The cells are then delivered to the hospital, where the surgeon
implants them into the patient's knee defect in a surgical procedure.
Carticel was the first cell therapy to be approved by the FDA. First
introduced in March of 1995, Carticel received accelerated approval from
the FDA in August of 1997 after the FDA instituted specific cell therapy
guidelines. Under accelerated approval, the FDA required Genzyme to conduct
confirmatory post-marketing studies.
To learn more about Carticel please visit carticel
Cell Therapy Expertise at Genzyme
Genzyme has more than a decade of experience in developing and
manufacturing autologous cell therapy products that have been used to treat
thousands of patients. Epicel(R) (cultured epidermal autografts), a cell
therapy for treating patients with severe burns, is also manufactured by
Genzyme. Together, Carticel and Epicel represent the first such products
ever brought to market in the United States, providing Genzyme with
superior scientific and commercial expertise in this field.
About Carticel
Carticel is for autologous use and is indicated for the repair of
symptomatic, cartilage defects of the femoral condyle (medial, lateral or
trochlea), caused by acute or repetitive trauma, in patients who have had
an inadequate response to a prior arthroscopic or other surgical repair
procedure (e.g., debridement, microfracture, drilling/abrasion
arthroplasty, or osteochondral allograft/autograft). Carticel should only
be used in conjunction with debridement, placement of a periosteal flap and
rehabilitation. The independent contributions of the autologous cultured
chondrocytes and other components of the therapy to outcome are unknown. It
is not indicated for the treatment of cartilage damage associated with
generalized osteoarthritis. It is not recommended for patients whose knee
meniscus has been surgically removed unless the patient has undergone
surgical reconstruction prior to or concurrent with Carticel implantation.
Pre-existing conditions including meniscal tears, joint instability or
malalignment of the joint should be corrected prior to or concurrent with
Carticel implantation. It should not be used in patients with a known
history of hypersensitivity to gentamicin, other aminoglycosides or
materials of bovine origin. Carticel is not routinely tested for
transmissible infectious diseases and may transmit disease to the
healthcare provider handling Carticel. In addition, it should not be used
in patients who have previously had cancer in the bones, cartilage, fat or
muscle of the treated limb. Use in children, patients over age 65, or in
joints other than the knee has not yet been assessed.
The occurrence of a subsequent surgical procedure, primarily
arthroscopy, following Carticel implantation is common. The most common
reactions (>5% of patients), derived from the Study of the Treatment of
Articular Repair (STAR), include arthrofibrosis/joint adhesions, graft
overgrowth, chondromalacia or chondrosis, cartilage injury, graft
complication, meniscal lesion, graft delamination, and osteoarthritis.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people with
serious diseases. Since 1981, the company has grown from a small start-up
to a diversified enterprise with more than 9,000 employees in locations
spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been
selected by FORTUNE as one of the "100 Best Companies to Work for" in the
United States.
With many established products and services helping patients in nearly
90 countries, Genzyme is a leader in the effort to develop and apply the
most advanced technologies in the life sciences. The company's products and
services are focused on rare inherited disorders, kidney disease,
orthopedics, cancer, transplant, and diagnostic testing. Genzyme's
commitment to innovation continues today with a substantial development
program focused on these fields, as well as immune disease, infectious
disease, and other areas of unmet medical need.
Genzyme Corporation
genzyme
понедельник, 25 апреля 2011 г.
Exercising After Menopause May Help Reduce Bone Loss
Early postmenopausal women with osteoporosis who participate in an intense exercise program may experience reduced bone loss, reduced back pain, and lower cholesterol levels, according to an article in the May 24 issue of The Archives of Internal Medicine, one of the JAMA/Archives journals.
According to information in the article, exercise can help prevent some of the negative consequences associated with menopause, such as bone loss, increased risk of cardiovascular disease, or chronic diseases, such as diabetes.
Wolfgang Kemmler, Ph.D., of the University of Erlangen, Germany, and colleagues investigated the effects of an intense exercise program on physical fitness, bone mineral density (BMD), back pain, and blood lipids (including cholesterol) in early postmenopausal women.
The researchers studied 50 early postmenopausal women (average age about 55 years) with osteoporosis who were not taking any medications and had no diseases that affect bone metabolism.
These women (the exercise group) participated in an exercise program that lasted 26 months and consisted of two supervised group training sessions (lasting 60 to 70 minutes each) per week, and two non-supervised home training sessions (25 minutes each) per week. Another 33 women (average age about 55 years) made up the non-exercising control group.
Both groups were given calcium and vitamin D supplements. Physical fitness, BMD, and blood lipid levels were assessed at the beginning and end of the study.
The researchers found that after 26 months, women in the exercise group were 36.5 percent more physically fit compared to when they started, vs. women in the control group, who were 1.7 percent more physically fit at the end of the study.
Measurements of BMD remained relatively stable for the exercise group, compared to decreases in BMD in the control group. Additionally, participants in the exercise group experienced less pain and had slightly reduced cholesterol levels compared to the control group.
"In this study we showed that a long-term multipurpose exercise program with emphasis on bone density not only offsets bone loss but also improves physical fitness and lower back pain and reduces some coronary heart disease risk factors in early postmenopausal women," the authors write.
(Arch Intern Med. 2004;164:1084-1091. Available post-embargo at archinternmed)
Editor's Note: Henning Ber-Sanofi Synthelabo (Berlin, Germany) supplied the calcium and cholecalciferol for all study participants. Therabands were supplied by Thera-Band GmbH (Hadamer, Germany). Additional support came from the Uni-Bund Erlangen.
For more information, contact JAMA/Archives Media Relations at 312/464-JAMA (5262) or e-mail mediarelationsjama-archives.
Contact: Wolfgang Kemmler, Ph.D.
wolfgang.kemmlerimp.uni-erlangen
JAMA and Archives Journals Website
According to information in the article, exercise can help prevent some of the negative consequences associated with menopause, such as bone loss, increased risk of cardiovascular disease, or chronic diseases, such as diabetes.
Wolfgang Kemmler, Ph.D., of the University of Erlangen, Germany, and colleagues investigated the effects of an intense exercise program on physical fitness, bone mineral density (BMD), back pain, and blood lipids (including cholesterol) in early postmenopausal women.
The researchers studied 50 early postmenopausal women (average age about 55 years) with osteoporosis who were not taking any medications and had no diseases that affect bone metabolism.
These women (the exercise group) participated in an exercise program that lasted 26 months and consisted of two supervised group training sessions (lasting 60 to 70 minutes each) per week, and two non-supervised home training sessions (25 minutes each) per week. Another 33 women (average age about 55 years) made up the non-exercising control group.
Both groups were given calcium and vitamin D supplements. Physical fitness, BMD, and blood lipid levels were assessed at the beginning and end of the study.
The researchers found that after 26 months, women in the exercise group were 36.5 percent more physically fit compared to when they started, vs. women in the control group, who were 1.7 percent more physically fit at the end of the study.
Measurements of BMD remained relatively stable for the exercise group, compared to decreases in BMD in the control group. Additionally, participants in the exercise group experienced less pain and had slightly reduced cholesterol levels compared to the control group.
"In this study we showed that a long-term multipurpose exercise program with emphasis on bone density not only offsets bone loss but also improves physical fitness and lower back pain and reduces some coronary heart disease risk factors in early postmenopausal women," the authors write.
(Arch Intern Med. 2004;164:1084-1091. Available post-embargo at archinternmed)
Editor's Note: Henning Ber-Sanofi Synthelabo (Berlin, Germany) supplied the calcium and cholecalciferol for all study participants. Therabands were supplied by Thera-Band GmbH (Hadamer, Germany). Additional support came from the Uni-Bund Erlangen.
For more information, contact JAMA/Archives Media Relations at 312/464-JAMA (5262) or e-mail mediarelationsjama-archives.
Contact: Wolfgang Kemmler, Ph.D.
wolfgang.kemmlerimp.uni-erlangen
JAMA and Archives Journals Website
Senator Obama Responds To Five Questions About His Health Care Plan To SpineUniverse
Senator Barack Obama, Democratic candidate for President, answered five questions about his health care plan to SpineUniverse. Now every visitor to SpineUniverse -- people who have an intense interest in the state of health care because of back pain or neck pain -- can examine how Sen. Obama's plan would affect them. (SpineUniverse also contacted Sen. John McCain's campaign, but he did not respond.)
Sen. Obama explained to SpineUniverse how:
- his plan would help the uninsured and underinsured in America
- the Obama-Biden plan would benefit small businesses through the Small Business Health Tax Credit
- his administration would ensure all children have medical coverage
- he would work to invest in technologies as a way to improve our health care system
He also gave three key points that voters should remember about the Obama-Biden health care plan, including that he will guarantee affordable, accessible coverage for all Americans. You can read Sen. Obama's answers here.
"Sen. Obama's health care plan includes an emphasis on preventive care, and that's a very important point for back and neck pain sufferers," explains Stephen Ondra, MD, Professor of Neurological Surgery at Northwestern University. "With accessible coverage for all, Americans will be able to get much-needed spinal care at the first sign of a problem, which may help them avoid developing a chronic back condition."
Ondra continues, "The Obama plan, with its emphasis on improving health IT, will also help spine patients receive better care by making it easier for medical professionals to coordinate care."
In conjunction with the Obama interview, SpineUniverse also just released results from its September 2008 survey that took a closer look at the politics of back pain. The results show an intriguing cross-section of America and should help voters think through the presidential candidates' health care plans.
Read full results from the SpineUniverse survey here.
In the survey, 96% of people said that back pain is a serious health concern--serious because it costs the American people time, productivity, and a lot of money. Every year, back and neck pain cost us $90 billion, and in a time of national penny-pinching, it makes sense that reducing back pain would be fiscally responsible.
Like so many proposed programs during this election year, Republicans and Democrats can't quite agree on how to reduce back pain and eventually reduce that $90 billion cost. 24% of Democrats believe that having affordable, quality care that's accessible by all would save our backs. Just 12% of Republicans chose universal health coverage as a viable option for back pain prevention, but 25% of Republicans think that encouraging weight loss would be the most effective way to reduce Americans' back pain.
It looks like even our approach to back pain labels us as red or blue. So when back pain sufferers head into the voting booth on Election Day--and 4 out of every 5 voters will have back pain at some point in their lives--they should think carefully about which candidate's health care plan they believe will help them the most.
About SpineUniverse
SpineUniverse, the most-visited spine-focused site on the web, provides online and offline resources for both patients and spine professionals. SpineUniverse helps patients and their families understand their back or neck problems with clear, straightforward explanations about what causes spinal problems and how they can be treated. SpineUniverse/professional features an industry-leading library of patient case studies and education resources. Relying on an 80 member Editorial Board of leading spine experts, SpineUniverse ensures that all information presented is trustworthy and of the highest quality.
SpineUniverse
Sen. Obama explained to SpineUniverse how:
- his plan would help the uninsured and underinsured in America
- the Obama-Biden plan would benefit small businesses through the Small Business Health Tax Credit
- his administration would ensure all children have medical coverage
- he would work to invest in technologies as a way to improve our health care system
He also gave three key points that voters should remember about the Obama-Biden health care plan, including that he will guarantee affordable, accessible coverage for all Americans. You can read Sen. Obama's answers here.
"Sen. Obama's health care plan includes an emphasis on preventive care, and that's a very important point for back and neck pain sufferers," explains Stephen Ondra, MD, Professor of Neurological Surgery at Northwestern University. "With accessible coverage for all, Americans will be able to get much-needed spinal care at the first sign of a problem, which may help them avoid developing a chronic back condition."
Ondra continues, "The Obama plan, with its emphasis on improving health IT, will also help spine patients receive better care by making it easier for medical professionals to coordinate care."
In conjunction with the Obama interview, SpineUniverse also just released results from its September 2008 survey that took a closer look at the politics of back pain. The results show an intriguing cross-section of America and should help voters think through the presidential candidates' health care plans.
Read full results from the SpineUniverse survey here.
In the survey, 96% of people said that back pain is a serious health concern--serious because it costs the American people time, productivity, and a lot of money. Every year, back and neck pain cost us $90 billion, and in a time of national penny-pinching, it makes sense that reducing back pain would be fiscally responsible.
Like so many proposed programs during this election year, Republicans and Democrats can't quite agree on how to reduce back pain and eventually reduce that $90 billion cost. 24% of Democrats believe that having affordable, quality care that's accessible by all would save our backs. Just 12% of Republicans chose universal health coverage as a viable option for back pain prevention, but 25% of Republicans think that encouraging weight loss would be the most effective way to reduce Americans' back pain.
It looks like even our approach to back pain labels us as red or blue. So when back pain sufferers head into the voting booth on Election Day--and 4 out of every 5 voters will have back pain at some point in their lives--they should think carefully about which candidate's health care plan they believe will help them the most.
About SpineUniverse
SpineUniverse, the most-visited spine-focused site on the web, provides online and offline resources for both patients and spine professionals. SpineUniverse helps patients and their families understand their back or neck problems with clear, straightforward explanations about what causes spinal problems and how they can be treated. SpineUniverse/professional features an industry-leading library of patient case studies and education resources. Relying on an 80 member Editorial Board of leading spine experts, SpineUniverse ensures that all information presented is trustworthy and of the highest quality.
SpineUniverse
воскресенье, 24 апреля 2011 г.
Mechanism Behind Rare Muscle Disorders Explained By Researchers
Researchers have provided the first thorough mechanistic account of how a genetic defect leads to malignant hypothermia (MH) and central core disease (CCD), rare genetic skeletal muscle disorders. The study appears in the January issue of the Journal of General Physiology.
Mutations in the type 1 ryanodine receptor (RYR1), the calcium release channel of the sarcoplasmic reticulum (SR) activated during skeletal muscle excitation-contraction (EC) coupling, give rise to CCD. One of the most common CCD-causing mutations is Ile4895Thr. Now, Robert Dirksen (University of Rochester) and colleagues have provided a comprehensive analysis of the consequences of this mutation in muscle fibers of adult mice heterozygous for the mutation.
The team addressed several questions concerning how RYR1 function is altered by the Ile4895Thr mutation. Their findings demonstrate, for the first time, that the muscle weakness associated with MH and CCD arises from a dominant-negative effect, a reduction in the magnitude and rate of calcium release by the mutant RYR1 receptors during EC coupling. The reduction in calcium release in turn leads to reduced muscle force generation.
Source:
David Greene
Rockefeller University Press
Mutations in the type 1 ryanodine receptor (RYR1), the calcium release channel of the sarcoplasmic reticulum (SR) activated during skeletal muscle excitation-contraction (EC) coupling, give rise to CCD. One of the most common CCD-causing mutations is Ile4895Thr. Now, Robert Dirksen (University of Rochester) and colleagues have provided a comprehensive analysis of the consequences of this mutation in muscle fibers of adult mice heterozygous for the mutation.
The team addressed several questions concerning how RYR1 function is altered by the Ile4895Thr mutation. Their findings demonstrate, for the first time, that the muscle weakness associated with MH and CCD arises from a dominant-negative effect, a reduction in the magnitude and rate of calcium release by the mutant RYR1 receptors during EC coupling. The reduction in calcium release in turn leads to reduced muscle force generation.
Source:
David Greene
Rockefeller University Press
суббота, 23 апреля 2011 г.
Small Bone Innovations, Inc. Receives US FDA 510(k) Clearance For Mini-Rail Fixation System And Large Cannulated Screw System
Small Bone Innovations, Inc. (SBi), a leading, privately-held orthopedics company focused exclusively on technologies and treatments for the small bones & joints, announced that it has received 510(k) pre-market clearance notifications from the U.S. Food and Drug Administration (FDA) for Mini-Rail Fixation System ('Mini-Rail System') and large Cannulated Screw System for use in lower limb reconstruction and repair procedures.
The Mini-Rail and Cannulated Screw systems further expand SBi's lower limb continuum of care product line.
SBi expects its Mini-Rail System to be used in common procedures such as first MTP (metatarsophalangeal) joint arthrodesis and distraction, subtalar fusion, and Jones fracture management. There are approximately 65,000 of these procedures performed annually in the U.S.*
The Mini-Rail System is a unique and highly adjustable fixation system that lets surgeons quickly achieve optimal placement in the bones of fixation "half" pins. The system's ease of use can decrease OR time. The Mini-Rail System was launched following a series of extensive evaluations by U.S. foot and ankle surgeons.
Guido LaPorta, DPM, FACFAS, Chief of Foot and Ankle Surgery at Community Medical Center, Scranton PA., said: "The SBi Mini-Rail System offers a versatile solution for small bone reconstruction and trauma. The system's design allows it to be used as primary or complementary fixation in arthrodesis, osteotomy, bone lengthening and fracture repair. The system's unique instrumentation allows us to employ the Mini-Rail System as an anatomically accurate and rigid construct."
SBi expects the large Cannulated Screw System, made out of stainless steel, to be used for a variety of foot and ankle procedures including triple arthrodesis, subtalar and ankle fusions. There are approximately 50,000 of these procedures performed annually in the U.S.*
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "Both the Mini-Rail and large Cannulated Screw systems have been designed specifically for use in a wide range of lower limb procedures to reinforce and enhance the company's goal of developing the most attractive, anatomically-focused product portfolio available for use by foot and ankle surgeons. These systems reinforce SBi's commitment to work with key opinion leaders to provide product solutions that serve the full range of clinical needs of surgeons and their patients."
* Source: Ortho Fact book - Knowledge Enterprise, 2005
Guido LaPorta, DPM, FACFAS provides consulting services to SBi.
Source
Small Bone Innovations, Inc.
The Mini-Rail and Cannulated Screw systems further expand SBi's lower limb continuum of care product line.
SBi expects its Mini-Rail System to be used in common procedures such as first MTP (metatarsophalangeal) joint arthrodesis and distraction, subtalar fusion, and Jones fracture management. There are approximately 65,000 of these procedures performed annually in the U.S.*
The Mini-Rail System is a unique and highly adjustable fixation system that lets surgeons quickly achieve optimal placement in the bones of fixation "half" pins. The system's ease of use can decrease OR time. The Mini-Rail System was launched following a series of extensive evaluations by U.S. foot and ankle surgeons.
Guido LaPorta, DPM, FACFAS, Chief of Foot and Ankle Surgery at Community Medical Center, Scranton PA., said: "The SBi Mini-Rail System offers a versatile solution for small bone reconstruction and trauma. The system's design allows it to be used as primary or complementary fixation in arthrodesis, osteotomy, bone lengthening and fracture repair. The system's unique instrumentation allows us to employ the Mini-Rail System as an anatomically accurate and rigid construct."
SBi expects the large Cannulated Screw System, made out of stainless steel, to be used for a variety of foot and ankle procedures including triple arthrodesis, subtalar and ankle fusions. There are approximately 50,000 of these procedures performed annually in the U.S.*
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "Both the Mini-Rail and large Cannulated Screw systems have been designed specifically for use in a wide range of lower limb procedures to reinforce and enhance the company's goal of developing the most attractive, anatomically-focused product portfolio available for use by foot and ankle surgeons. These systems reinforce SBi's commitment to work with key opinion leaders to provide product solutions that serve the full range of clinical needs of surgeons and their patients."
* Source: Ortho Fact book - Knowledge Enterprise, 2005
Guido LaPorta, DPM, FACFAS provides consulting services to SBi.
Source
Small Bone Innovations, Inc.
пятница, 22 апреля 2011 г.
Women On Osteoporosis Drug Can Discontinue Use With No Risk
A long-term study of the most widely used osteoporosis drug has found that many women can discontinue the drug after five years without increasing their fracture risk for as long as five more years.
The study on alendronate was led by researchers at the University of California, San Francisco, and findings are published in the December 27, 2006 issue of the "Journal of the American Medical Association." The research also showed that women at very high risk of painful spine fractures might be better-off continuing treatment.
"This has important implications as it has not been known whether treatment of osteoporosis should be continued indefinitely," said lead author Dennis Black, PhD, professor in the UCSF Department of Epidemiology and Biostatistics. "Because women with osteoporosis, particularly older post-menopausal women, often need to take multiple drugs, this would be welcome news for this group."
According to Black, shorter term studies of up to five years duration have shown reductions in fracture risk with alendronate treatment. This was the first study to examine the effects on fracture using the drug longer than five years, he said.
"We found that women who discontinued the drug had the same rate of non-spine fractures as women who continued using the drug," he said. "However, for clinically-recognized spine fractures, usually discovered due to back pain, continuing alendronate was better than discontinuing. And, if women choose to continue, we showed that 10 years of treatment is safe."
The new findings are from a follow-up study to the initial randomized trial that examined the effect of daily alendronate, a bisphosphonate or anti-resorptive drug, on bone mineral density and fracture risk in post-menopausal women with low BMD for up to 3.8 years.
Alendronate is used to reduce bone loss, increase bone density and reduce the risk of spine, wrist and hip fractures in postmenopausal women. Bisphosphonates are the most commonly used treatment for postmenopausal osteoporosis.
The initial study was named the Fracture Intervention Trial or FIT, and its results were reported in 1996 and 1998.
The follow-up study now being reported is known as FLEX, for FIT Long-Term Extension. It was designed to evaluate the effects on BMD for a total of 10 years, comparing those who continued to take the drug with those who stopped after five years. A total of 1,099 women who had previously received alendronate in FIT and afterwards, were re-randomized to receive placebo or alendronate at 5 mg or 10 mg daily.
According to Black, findings showed that "women randomized to continue taking alendronate did maintain a higher BMD at the hip and spine than those randomized to placebo. For those who stopped, there was a modest loss of BMD, but not a dramatic loss."
The study found differences in bone loss in those who continued versus those who stopped but the differences were surprisingly modest and there were no differences in rates of non-spine fractures or in spine fractures as assessed by comparison of spine x-rays. Severe spine fractures associated with painful symptoms were lower in those who continued but were relatively rare overall (5 percent in those who discontinued vs. 2.5 percent among those who continued drug treatment).
In the United States, osteoporosis affects about 44 million people age 50 and older, and of these, 80 percent are postmenopausal women.
According to Black, "Older people are often taking several different medications. But for many women, if they can discontinue one treatment after five years, it would also be a welcome lifestyle change and will decrease their overall costs for medical care."
A typical regimen requires the patient to drink a full glass of water with the drug on an empty stomach and sit upright for up to 30 minutes.
While the results suggest discontinuation of the treatment for some women, women at a very high risk of clinical spine fractures may benefit by continuing beyond five years, according to Black.
"In the future, we hope to be able to more specifically identify people who should continue and who should stop."
Co-authors of the study were Ann V. Schwartz, Douglas C. Bauer and Lisa Palmero, UCSF; Kristine E. Ensrud, VA Medical Center, Minneapolis; Jane A. Cauley, University of Pittsburgh; Silvina Levis, University of Miami; Sara A. Quandt, Wake Forest University; Suzanne Satterfield, University of Tennessee; Robert B. Wallace, University of Iowa; Lois E. Wehren, Antonio Lombardi and Arthur C. Santora, Merck Research Laboratories, NJ; and Steven R. Cummings, California Pacific Medical Center Research Institute, San Francisco.
UCSF served as the coordinating center for the FLEX study, funded by Merck & Co. In addition to receiving research funding, Black has served on Merck's speaker's bureau.
UCSF is a leading university that advances health worldwide by conducting advanced biomedical research, educating graduate students in the life sciences and health professions, and providing complex patient care.
Written by: Nancy Chan
University of California - San Francisco (UCSF)
ucsf
The study on alendronate was led by researchers at the University of California, San Francisco, and findings are published in the December 27, 2006 issue of the "Journal of the American Medical Association." The research also showed that women at very high risk of painful spine fractures might be better-off continuing treatment.
"This has important implications as it has not been known whether treatment of osteoporosis should be continued indefinitely," said lead author Dennis Black, PhD, professor in the UCSF Department of Epidemiology and Biostatistics. "Because women with osteoporosis, particularly older post-menopausal women, often need to take multiple drugs, this would be welcome news for this group."
According to Black, shorter term studies of up to five years duration have shown reductions in fracture risk with alendronate treatment. This was the first study to examine the effects on fracture using the drug longer than five years, he said.
"We found that women who discontinued the drug had the same rate of non-spine fractures as women who continued using the drug," he said. "However, for clinically-recognized spine fractures, usually discovered due to back pain, continuing alendronate was better than discontinuing. And, if women choose to continue, we showed that 10 years of treatment is safe."
The new findings are from a follow-up study to the initial randomized trial that examined the effect of daily alendronate, a bisphosphonate or anti-resorptive drug, on bone mineral density and fracture risk in post-menopausal women with low BMD for up to 3.8 years.
Alendronate is used to reduce bone loss, increase bone density and reduce the risk of spine, wrist and hip fractures in postmenopausal women. Bisphosphonates are the most commonly used treatment for postmenopausal osteoporosis.
The initial study was named the Fracture Intervention Trial or FIT, and its results were reported in 1996 and 1998.
The follow-up study now being reported is known as FLEX, for FIT Long-Term Extension. It was designed to evaluate the effects on BMD for a total of 10 years, comparing those who continued to take the drug with those who stopped after five years. A total of 1,099 women who had previously received alendronate in FIT and afterwards, were re-randomized to receive placebo or alendronate at 5 mg or 10 mg daily.
According to Black, findings showed that "women randomized to continue taking alendronate did maintain a higher BMD at the hip and spine than those randomized to placebo. For those who stopped, there was a modest loss of BMD, but not a dramatic loss."
The study found differences in bone loss in those who continued versus those who stopped but the differences were surprisingly modest and there were no differences in rates of non-spine fractures or in spine fractures as assessed by comparison of spine x-rays. Severe spine fractures associated with painful symptoms were lower in those who continued but were relatively rare overall (5 percent in those who discontinued vs. 2.5 percent among those who continued drug treatment).
In the United States, osteoporosis affects about 44 million people age 50 and older, and of these, 80 percent are postmenopausal women.
According to Black, "Older people are often taking several different medications. But for many women, if they can discontinue one treatment after five years, it would also be a welcome lifestyle change and will decrease their overall costs for medical care."
A typical regimen requires the patient to drink a full glass of water with the drug on an empty stomach and sit upright for up to 30 minutes.
While the results suggest discontinuation of the treatment for some women, women at a very high risk of clinical spine fractures may benefit by continuing beyond five years, according to Black.
"In the future, we hope to be able to more specifically identify people who should continue and who should stop."
Co-authors of the study were Ann V. Schwartz, Douglas C. Bauer and Lisa Palmero, UCSF; Kristine E. Ensrud, VA Medical Center, Minneapolis; Jane A. Cauley, University of Pittsburgh; Silvina Levis, University of Miami; Sara A. Quandt, Wake Forest University; Suzanne Satterfield, University of Tennessee; Robert B. Wallace, University of Iowa; Lois E. Wehren, Antonio Lombardi and Arthur C. Santora, Merck Research Laboratories, NJ; and Steven R. Cummings, California Pacific Medical Center Research Institute, San Francisco.
UCSF served as the coordinating center for the FLEX study, funded by Merck & Co. In addition to receiving research funding, Black has served on Merck's speaker's bureau.
UCSF is a leading university that advances health worldwide by conducting advanced biomedical research, educating graduate students in the life sciences and health professions, and providing complex patient care.
Written by: Nancy Chan
University of California - San Francisco (UCSF)
ucsf
четверг, 21 апреля 2011 г.
Guideline Reports A Lack Of Quality Research On Treating Orthopaedic Condition
The American Academy of Orthopaedic Surgeons (AAOS) Board of Directors approved and released a clinical practice guideline for treating osteochondritis dissecans (OCD) of the knee - a rare orthopaedic disorder that affects mostly physically active adolescents and young adults. This puzzling condition occurs when a piece of cartilage and bone detaches, and when severe, gets jammed between the moving parts of the bone, causing considerable pain in the joint. OCD of the knee can also lead to swelling and the inability to continue to play sports.
This clinical practice guideline was developed following a sweeping systematic review of the available high-quality (Level 1-3) literature from January 1966 through March 2010. This document addresses the diagnosis and treatment of of OCD in both children who were still growing (skeletally immature) and teenagers and adults who have completed their growth (skeletally mature).
Henry Chambers, MD, a pediatric orthopaedic surgeon who practices in San Diego, and serves as chair of the AAOS work study group on OCD of the knee, says, "We were humbled to realize that there are no adequate studies on either the operative or non-operative treatment of this problem. Nor are there any adequate studies on the evaluation of OCD by X-ray, MRI, CT scan, or bone scan. There also is a lack of research on which, if any, rehabilitation might alter the natural history of this disorder."
From the available evidence reviewed for this clinical practice guideline, it is the opinion of the AAOS work group that:
- Symptomatic skeletally immature patients with loose or completely detached lesions should be offered the option of surgery. There is, however, no support for any particular kind of surgery.
- Patients who remain symptomatic after treatment for OCD should have a repeat history and physical examination, X-rays, and/or MRI to assess healing.
- Patients who receive surgical treatment of OCD should be offered post-operative physical therapy.
"Ultimately, this review process has been a positive step for the AAOS and our patients," says Chambers. "The experience has given us the understanding of specific gaps in our knowledge and the direction future research must take. More importantly, we now have an understanding of how to proceed with prospective, multi-center controlled studies, which will allow us to come closer to some of these unknowns when treating this challenging condition."
The full guideline along with all supporting documentation and work group disclosures is available on the AAOS website.
Disclaimer: This Clinical Practice Guideline is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician's independent medical judgment, given the individual patient's clinical circumstances.
Note: A physician volunteer work group developed this Clinical Practice Guideline, based upon a systematic review of the current scientific and clinical information and accepted approaches to treatment and/or diagnosis. The entire process included a review panel consisting of internal and external committees, pubic commentaries, and final approval by the AAOS Board of Directors.
Source:
American Academy of Orthopaedic Surgeons
This clinical practice guideline was developed following a sweeping systematic review of the available high-quality (Level 1-3) literature from January 1966 through March 2010. This document addresses the diagnosis and treatment of of OCD in both children who were still growing (skeletally immature) and teenagers and adults who have completed their growth (skeletally mature).
Henry Chambers, MD, a pediatric orthopaedic surgeon who practices in San Diego, and serves as chair of the AAOS work study group on OCD of the knee, says, "We were humbled to realize that there are no adequate studies on either the operative or non-operative treatment of this problem. Nor are there any adequate studies on the evaluation of OCD by X-ray, MRI, CT scan, or bone scan. There also is a lack of research on which, if any, rehabilitation might alter the natural history of this disorder."
From the available evidence reviewed for this clinical practice guideline, it is the opinion of the AAOS work group that:
- Symptomatic skeletally immature patients with loose or completely detached lesions should be offered the option of surgery. There is, however, no support for any particular kind of surgery.
- Patients who remain symptomatic after treatment for OCD should have a repeat history and physical examination, X-rays, and/or MRI to assess healing.
- Patients who receive surgical treatment of OCD should be offered post-operative physical therapy.
"Ultimately, this review process has been a positive step for the AAOS and our patients," says Chambers. "The experience has given us the understanding of specific gaps in our knowledge and the direction future research must take. More importantly, we now have an understanding of how to proceed with prospective, multi-center controlled studies, which will allow us to come closer to some of these unknowns when treating this challenging condition."
The full guideline along with all supporting documentation and work group disclosures is available on the AAOS website.
Disclaimer: This Clinical Practice Guideline is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician's independent medical judgment, given the individual patient's clinical circumstances.
Note: A physician volunteer work group developed this Clinical Practice Guideline, based upon a systematic review of the current scientific and clinical information and accepted approaches to treatment and/or diagnosis. The entire process included a review panel consisting of internal and external committees, pubic commentaries, and final approval by the AAOS Board of Directors.
Source:
American Academy of Orthopaedic Surgeons
среда, 20 апреля 2011 г.
Women At Higher Risk Of Significant Bone Loss On Injectable Birth Control Identified By UTMB Study
Nearly half of women using depot medroxyprogesterone acetate (DMPA), commonly known as the birth control shot, will experience high bone mineral density (BMD) loss in the hip or lower spine within two years of beginning the contraceptive, according to researchers at the University of Texas Medical Branch at Galveston.
The study, reported in the January 2010 issue of Obstetrics and Gynecology, was the first to show that women on DMPA who smoke, have low levels of calcium intake and never gave birth are at the highest risk for BMD loss. The researchers also found that high risk women continued to experience significant losses in BMD during the third year of DMPA use, especially in the hip - the most common facture site in elderly women.
DMPA is an injected contraceptive administered to patients every three months. According to the American College of Obstetricians and Gynecologists, more than two million American women use DMPA, including approximately 400,000 teens. DMPA is relatively inexpensive compared with some other forms of birth control, has a low failure rate and doesn't need to be administered daily, which contributes to the contraceptive's popularity.
"Bone mineral density loss is not a significant concern for all women who choose DMPA," says senior author Dr. Abbey Berenson, professor in the department of obstetrics and gynecology and director of the Center for Interdisciplinary Research in Women's Health at UTMB.
According to Berenson, over the last several years there's been a fair amount of confusion about how to counsel patients. "Based on these findings, clinicians have the information they need to recommend basic behavior changes for high risk women to minimize BMD loss," she said.
The study followed 95 DMPA users for two years. In that time, 45 women had at least five percent BMD loss in the lower back or hip. A total of 50 women had less than five percent bone loss at both sites during the same period.
By and large, BMD loss was higher in women who were current smokers, had never given birth and had a daily calcium intake of 600 mg or less - far below the recommended amounts. Moreover, BMD loss substantially increased among the women with all three risk factors. Age, race or ethnicity, previous contraceptive use and body mass index were not associated with higher BMD loss.
The researchers followed 27 of the women for an additional year and found that those who experienced significant BMD loss in the first two years continued to lose bone mass.
"These losses, especially among women using DMPA for many years, are likely to take an extended period of time to reverse," says first author Dr. Mahburbur Rahman, assistant professor in the department of obstetrics and gynecology and Center for Interdisciplinary Research in Women's Health.
The researchers note that while this study will help physicians counsel women with modifiable risk factors who wish to use DMPA, prevention of bone loss while using the contraceptive and reversibility of BMD loss are still not well understood and further research is needed.
Source: Kristen Hensley
University of Texas Medical Branch at Galveston
The study, reported in the January 2010 issue of Obstetrics and Gynecology, was the first to show that women on DMPA who smoke, have low levels of calcium intake and never gave birth are at the highest risk for BMD loss. The researchers also found that high risk women continued to experience significant losses in BMD during the third year of DMPA use, especially in the hip - the most common facture site in elderly women.
DMPA is an injected contraceptive administered to patients every three months. According to the American College of Obstetricians and Gynecologists, more than two million American women use DMPA, including approximately 400,000 teens. DMPA is relatively inexpensive compared with some other forms of birth control, has a low failure rate and doesn't need to be administered daily, which contributes to the contraceptive's popularity.
"Bone mineral density loss is not a significant concern for all women who choose DMPA," says senior author Dr. Abbey Berenson, professor in the department of obstetrics and gynecology and director of the Center for Interdisciplinary Research in Women's Health at UTMB.
According to Berenson, over the last several years there's been a fair amount of confusion about how to counsel patients. "Based on these findings, clinicians have the information they need to recommend basic behavior changes for high risk women to minimize BMD loss," she said.
The study followed 95 DMPA users for two years. In that time, 45 women had at least five percent BMD loss in the lower back or hip. A total of 50 women had less than five percent bone loss at both sites during the same period.
By and large, BMD loss was higher in women who were current smokers, had never given birth and had a daily calcium intake of 600 mg or less - far below the recommended amounts. Moreover, BMD loss substantially increased among the women with all three risk factors. Age, race or ethnicity, previous contraceptive use and body mass index were not associated with higher BMD loss.
The researchers followed 27 of the women for an additional year and found that those who experienced significant BMD loss in the first two years continued to lose bone mass.
"These losses, especially among women using DMPA for many years, are likely to take an extended period of time to reverse," says first author Dr. Mahburbur Rahman, assistant professor in the department of obstetrics and gynecology and Center for Interdisciplinary Research in Women's Health.
The researchers note that while this study will help physicians counsel women with modifiable risk factors who wish to use DMPA, prevention of bone loss while using the contraceptive and reversibility of BMD loss are still not well understood and further research is needed.
Source: Kristen Hensley
University of Texas Medical Branch at Galveston
Ice Pack Reduces Pain And Improves Mobility Among Osteoarthritis Patients, Helps Athletes Recover More Quickly
A ground breaking ice pack, which reduces pain and improves joint mobility
among osteoarthritis patients and helps athletes recover quicker and more
effectively from injury or surgery, has been launched by North Yorkshire
healthcare innovations company - Salitas
The revolutionary MORPHO™ Cryo-Matrix remains colder up to 12 times longer
than conventional gel packs and is not wet or messy and is easy to prepare
and apply.
It can be programmed to stay at a constant 'cold' temperature (with a skin
interface temperature in the ideal (7-12°C zone) for up to four hours, as
opposed to the 20 minutes associated with conventional gel packs.
It is made from a unique matrix structure that moulds to the patients'
contours, even when they are moving; allowing patients to receive treatment
whilst taking part in exercise, training schedules or physiotherapy
programmes.
These unique features allow joints and muscles to be kept at the right
temperature, for the right amount of time, promoting faster recovery rates
after surgery or injury.
Ideal for professional sports people who want to get back to full fitness
fast, MORPHO™ can also be used as a long term treatment for osteoarthritis
patients - one of the most chronic diseases affecting the elderly. A recent
study carried out in Belgium concluded that if patients use MORPHO™
regularly it can be more effective than standard pharmacological treatments
such as paracetamol to relieve pain and improve joint mobility.
Richard Wilson, Managing Director at Salitas, said: "The MORPHO™ Cryo-Matrix
is a fantastic solution and has a number of unique qualities, which sets it
aside from other cryotherapy treatments across the globe. It ensures the
injured joint or muscle receives the right temperature, for the right length
of time, even when moving.
"It can be used by top athletes to aid the rehabilitation of acute sport
injuries, ease the effects of arthritis, rheumatism and multiple sclerosis
and help millions of patients recover from injuries faster."
salitas
among osteoarthritis patients and helps athletes recover quicker and more
effectively from injury or surgery, has been launched by North Yorkshire
healthcare innovations company - Salitas
The revolutionary MORPHO™ Cryo-Matrix remains colder up to 12 times longer
than conventional gel packs and is not wet or messy and is easy to prepare
and apply.
It can be programmed to stay at a constant 'cold' temperature (with a skin
interface temperature in the ideal (7-12°C zone) for up to four hours, as
opposed to the 20 minutes associated with conventional gel packs.
It is made from a unique matrix structure that moulds to the patients'
contours, even when they are moving; allowing patients to receive treatment
whilst taking part in exercise, training schedules or physiotherapy
programmes.
These unique features allow joints and muscles to be kept at the right
temperature, for the right amount of time, promoting faster recovery rates
after surgery or injury.
Ideal for professional sports people who want to get back to full fitness
fast, MORPHO™ can also be used as a long term treatment for osteoarthritis
patients - one of the most chronic diseases affecting the elderly. A recent
study carried out in Belgium concluded that if patients use MORPHO™
regularly it can be more effective than standard pharmacological treatments
such as paracetamol to relieve pain and improve joint mobility.
Richard Wilson, Managing Director at Salitas, said: "The MORPHO™ Cryo-Matrix
is a fantastic solution and has a number of unique qualities, which sets it
aside from other cryotherapy treatments across the globe. It ensures the
injured joint or muscle receives the right temperature, for the right length
of time, even when moving.
"It can be used by top athletes to aid the rehabilitation of acute sport
injuries, ease the effects of arthritis, rheumatism and multiple sclerosis
and help millions of patients recover from injuries faster."
salitas
Improving Recovery Of Soldiers With Severe Injuries
When a soldier is wounded during combat, surgeons must focus on reducing infection and reconstructing damaged bone and tissues. Technologies that could improve the repair and regeneration processes are being developed in research laboratories across the country, but they are not being moved quickly enough into military trauma centers.
Organizers of the recently established Georgia Tech Center for Advanced Bioengineering for Soldier Survivability want to change that.
"The goal of the center is to rapidly move new technologies from the laboratory to patients so that we can improve the quality of life for our veterans as they return from the wars the United States is fighting," said center director Barbara Boyan, the Price Gilbert, Jr. Chair in Tissue Engineering at the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.
The center will leverage the expertise of Georgia Tech researchers in musculoskeletal biology and regenerative medicine to quickly move tools that are clinically valuable, safe and effective from laboratories to use in trauma centers. To reduce the amount of time from invention to clinical use, engineers and scientists in the center work in teams that include a clinician with experience in combat medical care and a medical device industry partner.
Support for the center is provided by the Armed Forces Institute of Regenerative Medicine, the U.S. Army Institute of Surgical Research's Orthopedic Trauma Research Program, the U.S. Department of Defense and industry.
Researchers in the center will initially focus on ways to improve the healing of wounds, segmental bone defects and massive soft tissue defects. Traumatic injuries that affect the arms, legs, head and neck require technologies for treatment at the time of injury and in the ensuing days and months.
"These combat injuries are complicated to treat because they are large and typically infected, so even determining when a soldier should be treated for optimal recovery is a challenge," said Boyan, who is also the associate dean for research in Georgia Tech's College of Engineering. "It is not known whether a regenerative therapy will be most effective if used immediately following injury or at some later time after scar tissue has been established at the wound site."
By developing models that accurately reflect the complex aspects of injuries sustained by soldiers in combat, the researchers will be able to test assumptions about when to employ specific strategies and how to ensure their effectiveness. The models must also allow them to examine the use of technologies on both male and female patients, and on complex tissues that consist of nerves, a blood supply and multiple cell types.
"Since the processes of bone, vascular and neural formation are naturally linked during normal tissue development, growth and repair, our approach is to harness this knowledge by developing delivery strategies that present the right biologic cues in the right place at the right time to promote functional regeneration of multiple integrated tissues," said associate director of the center Robert Guldberg, a professor in Georgia Tech's Woodruff School of Mechanical Engineering.
To enhance tissue repair and regeneration following a traumatic injury, the researchers are focusing their efforts on stem cells. Even though stem cells have tremendous potential for repairing such defects, effective methods do not yet exist for delivering them to an injury site and of ensuring that they survive and remain at that site long enough to impact the regeneration process.
"Clinicians currently inject stem cells into a vein and hope that the cells will migrate to sites of injury and remain at those sites long enough to participate in the repair process. While some cells certainly do migrate to injury sites, the actual percentage is very small and those that arrive at the site do not remain to engraft with the host tissue," explained Boyan.
This limited effect may be the result of the injection process, according to Boyan, so researchers in the center are developing ways to protect the cells from damaging forces they might encounter when inserted into the body.
"Studies in our laboratory have shown that when stem cells are encapsulated in microbeads, they can be injected by needle without loss of cell viability and they remain at the injury site for at least two months," said Boyan.
Protecting the cells during insertion is just the first step toward improved tissue repair. The researchers must also examine whether the stem cells will turn into cells typical of the implanted tissue and if they produce or should be paired with molecules that can enhance the healing of the implanted tissues.
Center researchers are also investigating whether bone marrow-derived stem cells can be used in the body to heal large defects in bone and cartilage if they are inserted in fiber mesh scaffolds and silk sponges during a surgical procedure.
Additional projects in the center include assessing tissue viability, preventing the growth of bone in the soft tissues of the body and improving pre-hospital care of orthopedic injuries. Since effective treatment of traumatic injuries is an important goal for the general public as well as the military population, the researchers also hope to adapt their technologies for use in hospitals.
Other researchers in the center include Ravi Bellamkonda, a professor in the Coulter Department; Andres Garcia, the Woodruff Faculty Fellow in the Woodruff School of Mechanical Engineering; Robert Taylor, a professor in the Coulter Department and Emory's Division of Cardiology; Zvi Schwartz, a visiting professor in the Coulter Department; and U.S. Army surgical medicine consultants Michael Yaszemski and David Cohen.
Source:
Abby Vogel
Georgia Institute of Technology Research News
Organizers of the recently established Georgia Tech Center for Advanced Bioengineering for Soldier Survivability want to change that.
"The goal of the center is to rapidly move new technologies from the laboratory to patients so that we can improve the quality of life for our veterans as they return from the wars the United States is fighting," said center director Barbara Boyan, the Price Gilbert, Jr. Chair in Tissue Engineering at the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.
The center will leverage the expertise of Georgia Tech researchers in musculoskeletal biology and regenerative medicine to quickly move tools that are clinically valuable, safe and effective from laboratories to use in trauma centers. To reduce the amount of time from invention to clinical use, engineers and scientists in the center work in teams that include a clinician with experience in combat medical care and a medical device industry partner.
Support for the center is provided by the Armed Forces Institute of Regenerative Medicine, the U.S. Army Institute of Surgical Research's Orthopedic Trauma Research Program, the U.S. Department of Defense and industry.
Researchers in the center will initially focus on ways to improve the healing of wounds, segmental bone defects and massive soft tissue defects. Traumatic injuries that affect the arms, legs, head and neck require technologies for treatment at the time of injury and in the ensuing days and months.
"These combat injuries are complicated to treat because they are large and typically infected, so even determining when a soldier should be treated for optimal recovery is a challenge," said Boyan, who is also the associate dean for research in Georgia Tech's College of Engineering. "It is not known whether a regenerative therapy will be most effective if used immediately following injury or at some later time after scar tissue has been established at the wound site."
By developing models that accurately reflect the complex aspects of injuries sustained by soldiers in combat, the researchers will be able to test assumptions about when to employ specific strategies and how to ensure their effectiveness. The models must also allow them to examine the use of technologies on both male and female patients, and on complex tissues that consist of nerves, a blood supply and multiple cell types.
"Since the processes of bone, vascular and neural formation are naturally linked during normal tissue development, growth and repair, our approach is to harness this knowledge by developing delivery strategies that present the right biologic cues in the right place at the right time to promote functional regeneration of multiple integrated tissues," said associate director of the center Robert Guldberg, a professor in Georgia Tech's Woodruff School of Mechanical Engineering.
To enhance tissue repair and regeneration following a traumatic injury, the researchers are focusing their efforts on stem cells. Even though stem cells have tremendous potential for repairing such defects, effective methods do not yet exist for delivering them to an injury site and of ensuring that they survive and remain at that site long enough to impact the regeneration process.
"Clinicians currently inject stem cells into a vein and hope that the cells will migrate to sites of injury and remain at those sites long enough to participate in the repair process. While some cells certainly do migrate to injury sites, the actual percentage is very small and those that arrive at the site do not remain to engraft with the host tissue," explained Boyan.
This limited effect may be the result of the injection process, according to Boyan, so researchers in the center are developing ways to protect the cells from damaging forces they might encounter when inserted into the body.
"Studies in our laboratory have shown that when stem cells are encapsulated in microbeads, they can be injected by needle without loss of cell viability and they remain at the injury site for at least two months," said Boyan.
Protecting the cells during insertion is just the first step toward improved tissue repair. The researchers must also examine whether the stem cells will turn into cells typical of the implanted tissue and if they produce or should be paired with molecules that can enhance the healing of the implanted tissues.
Center researchers are also investigating whether bone marrow-derived stem cells can be used in the body to heal large defects in bone and cartilage if they are inserted in fiber mesh scaffolds and silk sponges during a surgical procedure.
Additional projects in the center include assessing tissue viability, preventing the growth of bone in the soft tissues of the body and improving pre-hospital care of orthopedic injuries. Since effective treatment of traumatic injuries is an important goal for the general public as well as the military population, the researchers also hope to adapt their technologies for use in hospitals.
Other researchers in the center include Ravi Bellamkonda, a professor in the Coulter Department; Andres Garcia, the Woodruff Faculty Fellow in the Woodruff School of Mechanical Engineering; Robert Taylor, a professor in the Coulter Department and Emory's Division of Cardiology; Zvi Schwartz, a visiting professor in the Coulter Department; and U.S. Army surgical medicine consultants Michael Yaszemski and David Cohen.
Source:
Abby Vogel
Georgia Institute of Technology Research News
Boning Up On New Osteoporosis Risk Guidelines
Osteoporosis - a skeletal disease that traditionally affects those age fifty and older - is a major public health problem. New guidelines released by the National Osteoporosis Foundation (NOF) call for bone mineral density (BMD) testing for all men ages seventy and older and for younger men with risk factors for bone loss. BMD testing is also urged for women sixty-five and older, and postmenopausal women that have risk factors for bone loss.
"These guidelines represent the newest advances healthcare professionals can use to identify and treat patients with low bone mass, risk of fracture, or osteoporosis," says noted expert Dr. Warren Levy, President and CEO of Unigene Laboratories. "As life expectancy rates continue to rise, osteoporosis will only have a greater impact on national health. The NOF guidelines will help physicians to diagnose and treat the disease."
Osteoporosis occurs when deteriorating tissue reduces bone density in the spine, hip, and other areas. Today, osteoporosis is a major health threat for forty-four million Americans, 80% of whom are women. In the United States, ten million individuals already have the disease while three times as many are believed to have osteopenia, a decrease in bone mineral density that can be a precursor condition to osteoporosis.
Fractures caused by either osteoporosis or low bone density can lead to chronic pain, disability, or worse. Fortunately, if osteoporosis does develop, various treatments are available.
The leading category of osteoporosis drugs is bisphosphonates, non-hormonal drugs that bind to bones to protect against tissue breakdown. However, recent reports have associated bisphosphonates with osteonecrosis ("bone death") of the jaw, severe bone/joint pain and potentially severe gastrointestinal side effects.
Alternative drug treatments for reduction in fracture risk do exist such as: calcitonin, parathyroid hormone, estrogen, and testosterone. Calcitonin is the active ingredient in Fortical, a nasal treatment developed by Unigene and marketed by Upsher-Smith Laboratories. "Nasal calcitonin products have been shown to help maintain proper bone density," says Dr. Levy.
While until now, the medical community had no clear guidelines for assessing fracture risk, Dr. Levy believes the new NOF guidelines will help to educate the public and medical community on the prevention and treatment of osteoporosis. "As in most things," says Dr. Levy, "education is a strong first line of defense."
unigene
"These guidelines represent the newest advances healthcare professionals can use to identify and treat patients with low bone mass, risk of fracture, or osteoporosis," says noted expert Dr. Warren Levy, President and CEO of Unigene Laboratories. "As life expectancy rates continue to rise, osteoporosis will only have a greater impact on national health. The NOF guidelines will help physicians to diagnose and treat the disease."
Osteoporosis occurs when deteriorating tissue reduces bone density in the spine, hip, and other areas. Today, osteoporosis is a major health threat for forty-four million Americans, 80% of whom are women. In the United States, ten million individuals already have the disease while three times as many are believed to have osteopenia, a decrease in bone mineral density that can be a precursor condition to osteoporosis.
Fractures caused by either osteoporosis or low bone density can lead to chronic pain, disability, or worse. Fortunately, if osteoporosis does develop, various treatments are available.
The leading category of osteoporosis drugs is bisphosphonates, non-hormonal drugs that bind to bones to protect against tissue breakdown. However, recent reports have associated bisphosphonates with osteonecrosis ("bone death") of the jaw, severe bone/joint pain and potentially severe gastrointestinal side effects.
Alternative drug treatments for reduction in fracture risk do exist such as: calcitonin, parathyroid hormone, estrogen, and testosterone. Calcitonin is the active ingredient in Fortical, a nasal treatment developed by Unigene and marketed by Upsher-Smith Laboratories. "Nasal calcitonin products have been shown to help maintain proper bone density," says Dr. Levy.
While until now, the medical community had no clear guidelines for assessing fracture risk, Dr. Levy believes the new NOF guidelines will help to educate the public and medical community on the prevention and treatment of osteoporosis. "As in most things," says Dr. Levy, "education is a strong first line of defense."
unigene
Magnetic Sensors Assist Surgeons
A recent achievement in biomedical technology is a magnetic sensor that enables orthopedic surgeons to find precise
alignments for metal implants used to repair broken bones.
Using the sensor, a surgeon will know the exact location for drilling holes in broken bone that line up with predrilled holes
in the implant.
Currently, surgeons perform bone implants using real-time X-rays as a guide. The problem with X-rays is harmful exposure,
which has motivated some doctors to seek an alternative.
According to the May 2005 issue of Mechanical Engineering, Carilion Biomedical Institute of Roanoke, Va., has developed a
prototype consisting of a fixed magnet placed in the hollow of the implant along with a handheld unit housing the sensors,
electronics, and drill sleeve.
In the procedure to mend a bone, the surgeon will guide the handheld unit until a liquid electronic display turns green,
indicating the sensors are centered over the magnet in the implant. With the drill holes aligned, the surgeon is then able to
drill through the bone.
Carilion says its device has been demonstrated on artificial femurs as well as on a cadaver. Carilion is currently
negotiating to license the technology, according to Mechanical Engineering, a publication of ASME.
To access the May 2005 issue of Mechanical Engineering, including the article "You Know the Drill," visit the ASME Web site
at asme.
Founded in 1880 as the American Society of Mechanical Engineers, today's ASME is a 120,000-member professional organization
focused on technical, educational and research issues of the worldwide engineering and technology community. In 2005, ASME
celebrates 125 years of continued service and leadership - setting the standard for professional engineering societies
worldwide.
ASME (American Society of Mechanical Engineers)
ASME Public Information, Three Park Ave.
New York, NY 10016-590
United States
asme/news
alignments for metal implants used to repair broken bones.
Using the sensor, a surgeon will know the exact location for drilling holes in broken bone that line up with predrilled holes
in the implant.
Currently, surgeons perform bone implants using real-time X-rays as a guide. The problem with X-rays is harmful exposure,
which has motivated some doctors to seek an alternative.
According to the May 2005 issue of Mechanical Engineering, Carilion Biomedical Institute of Roanoke, Va., has developed a
prototype consisting of a fixed magnet placed in the hollow of the implant along with a handheld unit housing the sensors,
electronics, and drill sleeve.
In the procedure to mend a bone, the surgeon will guide the handheld unit until a liquid electronic display turns green,
indicating the sensors are centered over the magnet in the implant. With the drill holes aligned, the surgeon is then able to
drill through the bone.
Carilion says its device has been demonstrated on artificial femurs as well as on a cadaver. Carilion is currently
negotiating to license the technology, according to Mechanical Engineering, a publication of ASME.
To access the May 2005 issue of Mechanical Engineering, including the article "You Know the Drill," visit the ASME Web site
at asme.
Founded in 1880 as the American Society of Mechanical Engineers, today's ASME is a 120,000-member professional organization
focused on technical, educational and research issues of the worldwide engineering and technology community. In 2005, ASME
celebrates 125 years of continued service and leadership - setting the standard for professional engineering societies
worldwide.
ASME (American Society of Mechanical Engineers)
ASME Public Information, Three Park Ave.
New York, NY 10016-590
United States
asme/news
First High-Flex Knee Replacement Implant Shaped Specifically To Fit Woman's Anatomy
The first knee replacement shaped to fit a woman's anatomy has received clearance from the U.S. Food and Drug Administration, and will be distributed to orthopedic surgeons to use next week. Dr. Aaron G. Rosenberg and Dr. Richard A. Berger, orthopedic surgeons at Rush University Medical Center, were two of the 10 developer surgeons who sought to address shape-related differences of a woman's knee.
The Gender Solutions High-Flex Knee, made by Zimmer, Inc, is designed based on three distinct and scientifically documented shape differences between women's and men's knees. The implant addresses the shape-related differences typical of a woman's knee: a narrower shape; thinner shape, and the need for more natural motion for the knee when walking.
"Knee implants have been functioning very well for men and women, but we want to meet women's unique needs by making knee replacements that feel, fit and function even better," says Rosenberg. "The implant is the best of both worlds. It's based on the current implant we use, a highly successful implant with great mechanics and 10 years of clinical success. Only the shape of this new implant is different, to make it feel more natural."
The clearance allows Zimmer to begin distributing the implant to U.S. orthopedic surgeons and hospitals as part of Zimmer's NexGen Complete Knee System. The Gender Solutions Knee will be implanted using existing, clinically successful surgical techniques, including Zimmer's minimally invasive approaches. Rosenberg and other surgeons who helped with development will be using the implant in patients next week. The implant is expected to be globally available this fall.
The Need for a Woman's Knee Implant
"Mounting research indicates that a woman's knee is not simply a smaller version of a man's knee. The differences involve the bones, ligaments and tendons in the joints," says Rosenberg. "Women can wear men's clothing and shoes, but most prefer clothing and shoes made for them. It's the same with knees, and it makes perfect sense to design knee implants with women in mind, particularly considering that women are by far the majority of the knee replacement patient population."
Nearly two-thirds of the more than 400,000 annual knee replacement patients are women, according to the National Center for Health Statistics, and the numbers continue to increase each year. Research shows that while both women and men vastly under use knee replacement, women are three times less likely than men to undergo the procedure, although they suffer from more knee pain and resulting disability.
"Less invasive procedures are helping patients get back to enjoying their lives faster than ever before. Now that we have a knee shaped to fit women's anatomy, we expect far more women will want to consider knee replacement."
Knee replacements have long been available in many sizes, but merely using a different size for women doesn't resolve anatomical differences. Various studies show that women's knees significantly differ in shape from men's knees. Pioneering research conducted for Zimmer precisely maps out those differences and is the foundation for the design and development of the female implant.
The female implant can be placed using minimally invasive techniques which typically offer smaller scars, shorter hospitalization and quicker rehabilitation and recovery; and safely accommodates high flexion (up to 155 degrees), which is necessary for many activities, such as climbing stairs, sitting in a chair, gardening and golfing.
The knee joint is composed of three bones: the end of the femur (thighbone), the top of the tibia (shinbone) and the patella (kneecap), which are all held together by tendons and ligaments and cushioned by cartilage. Knees can become painful, due to arthritis, injury and infection, which cause deterioration of the cartilage. When the cartilage is gone, the bones of the knee grind against each other, wearing away and typically causing severe pain. Total knee replacement involves removing the portion of bone that is damaged and resurfacing the knee with metal and plastic implants.
Historically, implants used for knee replacement have been designed based upon an average between the size of women's and men's knees. Total knee replacement is a highly successful surgery, strongly supported by more than 20 years of follow-up data, according to the National Institutes of Health (NIH) consensus statement on total knee replacement released in February 2004. The NIH consensus panel concluded that total knee replacement provides substantial improvement in patients' pain, functional status, and overall health-related quality of life in about nine out of 10 patients.
Three Distinct Differences
The Gender Solutions implant addresses the following research-documented, shape-related differences of a woman's knee:
-- Narrower Shape, Proportioned to Female Anatomy: When determining the appropriate-sized implant, surgeons measure the end of the femur from front to back and from side to side. Women's knees typically are narrower from side to side, and are more trapezoid-shaped, whereas men's knees are more rectangle-shaped. Surgeons typically choose the implant size based on the front-to-back measurement, which is key in allowing the knee to move and flex properly. However, an implant that fits a woman's knee from front to back often will be too wide from side to side, leading to the implant overhanging the bone and potentially pressing on, or damaging, surrounding ligaments and tendons, possibly causing pain. The Gender Solutions knee is proportionally contoured to the entire bone to provide a more precise fit.
-- Thinner Shape: The bone in the front of a woman's knee is typically less prominent than in a man's knee. Therefore, when a traditional implant is used to replace the damaged bone, the joint may end up feeling and functioning better than before surgery but still feel "bulky," which may result in pain and decrease optimal function. This implant is thinner in shape in the front so the knee replacement more appropriately matches the natural female anatomy.
-- More Natural Tracking: The angle between the pelvis and the knee affects how the kneecap tracks over the end of the femur as the knee moves through a range of motion. Women tend to have a different angle than men due to their specific shape and contour. The Gender Solutions Knee Implant was designed to accommodate the different tracking angle and function more like a woman's natural knee.
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The Gender Solutions High-Flex Knee, made by Zimmer, Inc, is designed based on three distinct and scientifically documented shape differences between women's and men's knees. The implant addresses the shape-related differences typical of a woman's knee: a narrower shape; thinner shape, and the need for more natural motion for the knee when walking.
"Knee implants have been functioning very well for men and women, but we want to meet women's unique needs by making knee replacements that feel, fit and function even better," says Rosenberg. "The implant is the best of both worlds. It's based on the current implant we use, a highly successful implant with great mechanics and 10 years of clinical success. Only the shape of this new implant is different, to make it feel more natural."
The clearance allows Zimmer to begin distributing the implant to U.S. orthopedic surgeons and hospitals as part of Zimmer's NexGen Complete Knee System. The Gender Solutions Knee will be implanted using existing, clinically successful surgical techniques, including Zimmer's minimally invasive approaches. Rosenberg and other surgeons who helped with development will be using the implant in patients next week. The implant is expected to be globally available this fall.
The Need for a Woman's Knee Implant
"Mounting research indicates that a woman's knee is not simply a smaller version of a man's knee. The differences involve the bones, ligaments and tendons in the joints," says Rosenberg. "Women can wear men's clothing and shoes, but most prefer clothing and shoes made for them. It's the same with knees, and it makes perfect sense to design knee implants with women in mind, particularly considering that women are by far the majority of the knee replacement patient population."
Nearly two-thirds of the more than 400,000 annual knee replacement patients are women, according to the National Center for Health Statistics, and the numbers continue to increase each year. Research shows that while both women and men vastly under use knee replacement, women are three times less likely than men to undergo the procedure, although they suffer from more knee pain and resulting disability.
"Less invasive procedures are helping patients get back to enjoying their lives faster than ever before. Now that we have a knee shaped to fit women's anatomy, we expect far more women will want to consider knee replacement."
Knee replacements have long been available in many sizes, but merely using a different size for women doesn't resolve anatomical differences. Various studies show that women's knees significantly differ in shape from men's knees. Pioneering research conducted for Zimmer precisely maps out those differences and is the foundation for the design and development of the female implant.
The female implant can be placed using minimally invasive techniques which typically offer smaller scars, shorter hospitalization and quicker rehabilitation and recovery; and safely accommodates high flexion (up to 155 degrees), which is necessary for many activities, such as climbing stairs, sitting in a chair, gardening and golfing.
The knee joint is composed of three bones: the end of the femur (thighbone), the top of the tibia (shinbone) and the patella (kneecap), which are all held together by tendons and ligaments and cushioned by cartilage. Knees can become painful, due to arthritis, injury and infection, which cause deterioration of the cartilage. When the cartilage is gone, the bones of the knee grind against each other, wearing away and typically causing severe pain. Total knee replacement involves removing the portion of bone that is damaged and resurfacing the knee with metal and plastic implants.
Historically, implants used for knee replacement have been designed based upon an average between the size of women's and men's knees. Total knee replacement is a highly successful surgery, strongly supported by more than 20 years of follow-up data, according to the National Institutes of Health (NIH) consensus statement on total knee replacement released in February 2004. The NIH consensus panel concluded that total knee replacement provides substantial improvement in patients' pain, functional status, and overall health-related quality of life in about nine out of 10 patients.
Three Distinct Differences
The Gender Solutions implant addresses the following research-documented, shape-related differences of a woman's knee:
-- Narrower Shape, Proportioned to Female Anatomy: When determining the appropriate-sized implant, surgeons measure the end of the femur from front to back and from side to side. Women's knees typically are narrower from side to side, and are more trapezoid-shaped, whereas men's knees are more rectangle-shaped. Surgeons typically choose the implant size based on the front-to-back measurement, which is key in allowing the knee to move and flex properly. However, an implant that fits a woman's knee from front to back often will be too wide from side to side, leading to the implant overhanging the bone and potentially pressing on, or damaging, surrounding ligaments and tendons, possibly causing pain. The Gender Solutions knee is proportionally contoured to the entire bone to provide a more precise fit.
-- Thinner Shape: The bone in the front of a woman's knee is typically less prominent than in a man's knee. Therefore, when a traditional implant is used to replace the damaged bone, the joint may end up feeling and functioning better than before surgery but still feel "bulky," which may result in pain and decrease optimal function. This implant is thinner in shape in the front so the knee replacement more appropriately matches the natural female anatomy.
-- More Natural Tracking: The angle between the pelvis and the knee affects how the kneecap tracks over the end of the femur as the knee moves through a range of motion. Women tend to have a different angle than men due to their specific shape and contour. The Gender Solutions Knee Implant was designed to accommodate the different tracking angle and function more like a woman's natural knee.
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Hundreds Of Thousands Celebrate 'Move It Or Lose It!' World Osteoporosis Day 2005 A Success
Hundreds of thousands of people around the world joined in the fight against osteoporosis and celebrated World Osteoporosis Day (WOD) 2005, the International Osteoporosis Foundation said today.
"IOF is delighted by how many people embraced the theme of 'Move it or Lose it!' as we encourage women and men to realize that they can take responsibility for their bone health and not be victims of osteoporosis later in life," said IOF Chief Executive Officer Daniel Navid.
In Berlin on World Osteoporosis Day, October 20, the IOF launched the popular report "Move it or Lose it - How exercise helps to build and maintain strong bones, prevent falls and fractures, and speed rehabilitation" by Professor Helmut Minne. This report has been translated into more than 30 languages.
In other World Osteoporosis Day activities:
-- Seven beauty queens championed strong bones, the role of exercise, and the need for young girls to build strong bones through adequate exercise and healthy nutrition, at a media event in Bangkok, Thailand on September 27.
-- IOF released the song "Un Cuerpo Sano/A Healthy Body" by Erika Ender.
-- Ten public service announcements which featured international celebrities who urged people to take charge of their own bone health, avoid osteoporosis and "move it or lose it" were produced and broadcast throughout the world.
-- Many of IOF's 172 member societies in more than 80 countries, on all continents, conducted World Osteoporosis Day campaigns, reaching more than 50% of the world's population.
-- The number of media print impressions worldwide as a result of WOD activities is more than 32 million.
This year's WOD theme marked the beginning of a three-year "lifestyle" campaign, encouraging individuals to take responsibility for personal bone health. The World Osteoporosis Day 2006 theme "Bone Appetit" will focus on the role of nutrition in building strong bones and the prevention of osteoporosis.
Understanding and reducing personal risk factors for osteoporosis will be the theme for World Osteoporosis Day in 2007.
For a full report of WOD around the world, Click Here.
Osteoporosis, in which the bones become porous and break easily, is one of the world's most common and debilitating diseases. The result: pain, loss of movement, inability to perform daily chores, and in many cases death. One out of three women over 50 will experience osteoporotic fractures, as will one out of five men 1, 2, 3. Unfortunately, screening for people at risk is far from being a standard practice. Osteoporosis can, to a certain extent, be prevented, it can be easily diagnosed and effective treatments are available.
The International Osteoporosis Foundation (IOF) is the only worldwide organization dedicated to the fight against osteoporosis. It brings together scientists, physicians, patient societies and corporate partners. Working with its 170 member societies in 84 locations, and other healthcare-related organizations around the world, IOF encourages awareness and prevention, early detection and improved treatment of osteoporosis.
1.Melton U, Chrischilles EA, Cooper C et al. How many women have osteoporosis? Journal of Bone Mineral Research, 1992; 7:1005-10
2.Kanis JA et al. Long-term risk of osteoporotic fracture in Malmo. Osteoporosis International, 2000; 11:669-674
3.Melton LJ, et al. Bone density and fracture risk in men. JBMR. 1998; 13:No 12:1915
International Osteoporosis Foundation 2005 Osteoporosis Journalism Awards. These awards recognize outstanding print reporting about osteoporosis. With prizes of USD 17,000, the closing date for award entries is January 31, 2006. For more information please go to osteofound/press_centre/journalism_award.html
For more information on osteoporosis and IOF, and to download the music video and the Public Service Announcements, please visit: osteofound/press_centre/index.html
Janice Blondeau
jblondeauosteofound
International Osteoporosis Foundation
osteofound
"IOF is delighted by how many people embraced the theme of 'Move it or Lose it!' as we encourage women and men to realize that they can take responsibility for their bone health and not be victims of osteoporosis later in life," said IOF Chief Executive Officer Daniel Navid.
In Berlin on World Osteoporosis Day, October 20, the IOF launched the popular report "Move it or Lose it - How exercise helps to build and maintain strong bones, prevent falls and fractures, and speed rehabilitation" by Professor Helmut Minne. This report has been translated into more than 30 languages.
In other World Osteoporosis Day activities:
-- Seven beauty queens championed strong bones, the role of exercise, and the need for young girls to build strong bones through adequate exercise and healthy nutrition, at a media event in Bangkok, Thailand on September 27.
-- IOF released the song "Un Cuerpo Sano/A Healthy Body" by Erika Ender.
-- Ten public service announcements which featured international celebrities who urged people to take charge of their own bone health, avoid osteoporosis and "move it or lose it" were produced and broadcast throughout the world.
-- Many of IOF's 172 member societies in more than 80 countries, on all continents, conducted World Osteoporosis Day campaigns, reaching more than 50% of the world's population.
-- The number of media print impressions worldwide as a result of WOD activities is more than 32 million.
This year's WOD theme marked the beginning of a three-year "lifestyle" campaign, encouraging individuals to take responsibility for personal bone health. The World Osteoporosis Day 2006 theme "Bone Appetit" will focus on the role of nutrition in building strong bones and the prevention of osteoporosis.
Understanding and reducing personal risk factors for osteoporosis will be the theme for World Osteoporosis Day in 2007.
For a full report of WOD around the world, Click Here.
Osteoporosis, in which the bones become porous and break easily, is one of the world's most common and debilitating diseases. The result: pain, loss of movement, inability to perform daily chores, and in many cases death. One out of three women over 50 will experience osteoporotic fractures, as will one out of five men 1, 2, 3. Unfortunately, screening for people at risk is far from being a standard practice. Osteoporosis can, to a certain extent, be prevented, it can be easily diagnosed and effective treatments are available.
The International Osteoporosis Foundation (IOF) is the only worldwide organization dedicated to the fight against osteoporosis. It brings together scientists, physicians, patient societies and corporate partners. Working with its 170 member societies in 84 locations, and other healthcare-related organizations around the world, IOF encourages awareness and prevention, early detection and improved treatment of osteoporosis.
1.Melton U, Chrischilles EA, Cooper C et al. How many women have osteoporosis? Journal of Bone Mineral Research, 1992; 7:1005-10
2.Kanis JA et al. Long-term risk of osteoporotic fracture in Malmo. Osteoporosis International, 2000; 11:669-674
3.Melton LJ, et al. Bone density and fracture risk in men. JBMR. 1998; 13:No 12:1915
International Osteoporosis Foundation 2005 Osteoporosis Journalism Awards. These awards recognize outstanding print reporting about osteoporosis. With prizes of USD 17,000, the closing date for award entries is January 31, 2006. For more information please go to osteofound/press_centre/journalism_award.html
For more information on osteoporosis and IOF, and to download the music video and the Public Service Announcements, please visit: osteofound/press_centre/index.html
Janice Blondeau
jblondeauosteofound
International Osteoporosis Foundation
osteofound
Potential To Restore Range Of Motion, Accelerate Healing Using Freeze-Dried Tendon Implants
Donated, freeze-dried tendon grafts loaded with gene therapy may soon offer effective repair of injured tendons, a goal that has eluded surgeons to date. According to study data published in the journal Molecular Therapy, a new graft technique may provide the first effective framework around which flexor tendon tissue can reorganize as it heals. Such tissue-engineering approaches could significantly improve repair of anterior cruciate ligaments and rotator cuffs as well, researchers said. The study was in a mouse model designed to resemble hard-to-repair flexor tendons in human hands, and the results should provide an impetus for future clinical trials.
Tendons are elastic cords that anchor muscle to bone and enable flexing muscle to move limbs. Related injuries represent nearly half of 33 million U.S. orthopaedic injuries each year, and a frequent cause of emergency room visits. In many standard repair attempts, surgeons implant an autograft, a piece of tendon from elsewhere in the same patient. Along with requiring patients to sacrifice tendon, the problem with "live" autografts is that both the graft and the graft site "know" they have been injured. That signals immune cells and chemicals to rush into the graft site, seeking to fight infection. Unfortunately, those same processes cause inflammation and scarring, which in turn cause implanted tendon to stick to the joint. To work properly, the tendon must be free to glide across the joint. Tendon adhesions, a longstanding post-surgical problem, cause pain and permanently limit range of motion.
Researchers next experimented with allografts: tendons donated from one person to another. Clinically, this technique fared worse than autografts because patients' bodies would recognize the donated tendon as foreign, attempt to wall it off with fibrous proteins and in some cases reject the transplant. The field then looked at whether synthetic scaffolds made of gel or fiber mesh could serve as alternatives. Theoretically, such materials would guide damaged tissue as it reorganizes into healthy tendon without causing an immune reaction. They could be coated with anti-inflammatory drugs, growth factors or gene therapy vectors to drive healing and reduce swelling. Unfortunately, artificial grafts too failed to yield useful tendon substitutes because they did not match the mechanical strength of human tissue.
In the newly published study, a research team from the University of Rochester Medical Center explored yet another option: the implantation of allografts (donated, freeze-dried tendon) loaded with gene therapy. Their results show that the allografts served as effective tissue-engineered scaffolds, with significantly fewer adhesions than seen with autografts. The allografts also sucked up, and delivered into the graft site, a solution of gene therapy vectors that directed the recipient's cells to accept the graft and remodel it into living tissue.
"Orthopaedic surgeons have been searching for the perfect material to replace tendon, one with the right mix of strength and elasticity and would not cause adhesion," said Hani Awad, Ph.D., assistant professor of Biomedical Engineering and Orthopaedics within the Center for Musculoskeletal Research at the Medical Center. "We believe the only material to meet these strict requirements is non-living, but structurally intact tendon. We were surprised to find that no one had tried combining it with gene therapy or other drug delivery techniques to overcome its limitations," said Awad, also senior author of the study.
Study Details
Tendon, like bone and cartilage, is connective tissue made up of tough protein fibers. The quality that enables tendon allografts to overcome past limitations is that such connective tissues naturally contain depots designed to hold signaling molecules. In the current study, tissue engineers filled those depots with gene delivery vectors.
In general, gene therapy inserts genes into cells, where they direct the target cell's own genetic machinery to make a desired protein. In the current study, the inserted gene called for the building of a growth factor that directs cells to divide and tissues to grow, or heal. To deliver genes into cells, gene therapies rely on viruses (vectors) designed by evolution to penetrate human cells and insert their own DNA. Viral vectors retain this ability, but have been harnessed to deliver therapeutic genes. Specifically, Awad's team implanted into the distal flexor digitorum longus (FDL) tendons of mice a freeze-dried allograft loaded with a recombinant adeno-associated vector (rAAV) expressing the gene that codes for the building of growth and differentiation factor 5 (Gdf5). A control group received an allograft loaded with a non-therapeutic gene (lacZ). Functional recovery was then compared between groups.
In past studies, rAAV vectors have proven to be safe because they make temporary changes to DNA, but then stop before too much re-growth can pose cancer risk. GDF5 was chosen because it is known to direct the formation of tendon in the womb. Similar to skin, tendons heal via the formation of a scar, but that process in tendon leads to imperfect tissue growth that adheres to the joint and compromises function. The hope was that adding extra GDF5 would help, and the data indeed show that animals with freeze-dried FDL allografts loaded with rAAV Gdf5 recovered twice the range of motion when compared to the control group at 14 days post surgery. At 28 days after surgery, the allograft group had reached nearly 65 percent of the normal range of motion, compared to the control group, which had recovered only 35 percent of the normal range.
Current rehabilitation programs take advantage of the fact that the gliding and stretching of tendon as it heals has been shown to accelerate healing. Various forms of passive, controlled motion (physical therapy) are commonplace. A limitation of the current study was that the mouse tendon allografts used were so small that the tendon had to be immobilized during the healing process to prevent tearing. Thus, the results showed that overall healing of the two groups - GDF-treated and control - proceeded at the same rate over the first 84 days after reconstruction. In larger animals and in humans, where allografts should be able to benefit from the force of motion as they heal, Awad expects that gene-therapy-loaded allografts will heal at a much faster rate than autografts or synthetic grafts. That theory has yet to be proven however.
Should this line of work prove successful, existing tissue banks could be refitted to create a nationwide supply of therapeutically enhanced tendons for transplant, according to the study authors. Millions of bone and cartilage grafts are already used in orthopaedics, as well as in plastic and general surgery. The banks are made possible by conscientious donors that indicate in their wills, or on their licenses, that their tissue is to be donated upon their death.
Along with Awad, study authors were Patrick Basile, M.D., Tulin Dadali, B.S., Justin Jacobson, M.D., Yasuhiko Nishio, Ph.D., M. Hicham Drissi, Ph.D., Howard Langstein, M.D., David Mitten, M.D., Regis J O'Keefe, M.D., Ph.D., and Edward Schwarz, Ph.D. from the University of Rochester Medical Center as well as Sys Hasslund, Michael Ulrich-Vinther and Kjeld SГёballe from Aarhus University Hospital in Denmark. The team will next seek to determine the mechanisms by which growth factors repair tendons. After that, studies will move into larger animals and humans, potentially within a few years.
"Tendon is very durable," said Regis O'Keefe, M.D., Ph.D., chair of the Department of Orthopaedics and Rehabilitation at the University of Rochester Medical Center, and a study author. "It could conceivably be freeze-dried, thawed and then freeze-dried again without damaging it. It could be left on shelves at tissue banks indefinitely and then shipped long distances. To get it ready for surgery, you would thaw it in a solution containing growth factors, cut it to size on the spot and implant it. While we acknowledge that this work is in mice, that there are differences between species and that more work needs to be done, we believe these results promise practical yet dramatic improvements in reconstructive surgery."
Source: Greg Williams
University of Rochester Medical Center
Tendons are elastic cords that anchor muscle to bone and enable flexing muscle to move limbs. Related injuries represent nearly half of 33 million U.S. orthopaedic injuries each year, and a frequent cause of emergency room visits. In many standard repair attempts, surgeons implant an autograft, a piece of tendon from elsewhere in the same patient. Along with requiring patients to sacrifice tendon, the problem with "live" autografts is that both the graft and the graft site "know" they have been injured. That signals immune cells and chemicals to rush into the graft site, seeking to fight infection. Unfortunately, those same processes cause inflammation and scarring, which in turn cause implanted tendon to stick to the joint. To work properly, the tendon must be free to glide across the joint. Tendon adhesions, a longstanding post-surgical problem, cause pain and permanently limit range of motion.
Researchers next experimented with allografts: tendons donated from one person to another. Clinically, this technique fared worse than autografts because patients' bodies would recognize the donated tendon as foreign, attempt to wall it off with fibrous proteins and in some cases reject the transplant. The field then looked at whether synthetic scaffolds made of gel or fiber mesh could serve as alternatives. Theoretically, such materials would guide damaged tissue as it reorganizes into healthy tendon without causing an immune reaction. They could be coated with anti-inflammatory drugs, growth factors or gene therapy vectors to drive healing and reduce swelling. Unfortunately, artificial grafts too failed to yield useful tendon substitutes because they did not match the mechanical strength of human tissue.
In the newly published study, a research team from the University of Rochester Medical Center explored yet another option: the implantation of allografts (donated, freeze-dried tendon) loaded with gene therapy. Their results show that the allografts served as effective tissue-engineered scaffolds, with significantly fewer adhesions than seen with autografts. The allografts also sucked up, and delivered into the graft site, a solution of gene therapy vectors that directed the recipient's cells to accept the graft and remodel it into living tissue.
"Orthopaedic surgeons have been searching for the perfect material to replace tendon, one with the right mix of strength and elasticity and would not cause adhesion," said Hani Awad, Ph.D., assistant professor of Biomedical Engineering and Orthopaedics within the Center for Musculoskeletal Research at the Medical Center. "We believe the only material to meet these strict requirements is non-living, but structurally intact tendon. We were surprised to find that no one had tried combining it with gene therapy or other drug delivery techniques to overcome its limitations," said Awad, also senior author of the study.
Study Details
Tendon, like bone and cartilage, is connective tissue made up of tough protein fibers. The quality that enables tendon allografts to overcome past limitations is that such connective tissues naturally contain depots designed to hold signaling molecules. In the current study, tissue engineers filled those depots with gene delivery vectors.
In general, gene therapy inserts genes into cells, where they direct the target cell's own genetic machinery to make a desired protein. In the current study, the inserted gene called for the building of a growth factor that directs cells to divide and tissues to grow, or heal. To deliver genes into cells, gene therapies rely on viruses (vectors) designed by evolution to penetrate human cells and insert their own DNA. Viral vectors retain this ability, but have been harnessed to deliver therapeutic genes. Specifically, Awad's team implanted into the distal flexor digitorum longus (FDL) tendons of mice a freeze-dried allograft loaded with a recombinant adeno-associated vector (rAAV) expressing the gene that codes for the building of growth and differentiation factor 5 (Gdf5). A control group received an allograft loaded with a non-therapeutic gene (lacZ). Functional recovery was then compared between groups.
In past studies, rAAV vectors have proven to be safe because they make temporary changes to DNA, but then stop before too much re-growth can pose cancer risk. GDF5 was chosen because it is known to direct the formation of tendon in the womb. Similar to skin, tendons heal via the formation of a scar, but that process in tendon leads to imperfect tissue growth that adheres to the joint and compromises function. The hope was that adding extra GDF5 would help, and the data indeed show that animals with freeze-dried FDL allografts loaded with rAAV Gdf5 recovered twice the range of motion when compared to the control group at 14 days post surgery. At 28 days after surgery, the allograft group had reached nearly 65 percent of the normal range of motion, compared to the control group, which had recovered only 35 percent of the normal range.
Current rehabilitation programs take advantage of the fact that the gliding and stretching of tendon as it heals has been shown to accelerate healing. Various forms of passive, controlled motion (physical therapy) are commonplace. A limitation of the current study was that the mouse tendon allografts used were so small that the tendon had to be immobilized during the healing process to prevent tearing. Thus, the results showed that overall healing of the two groups - GDF-treated and control - proceeded at the same rate over the first 84 days after reconstruction. In larger animals and in humans, where allografts should be able to benefit from the force of motion as they heal, Awad expects that gene-therapy-loaded allografts will heal at a much faster rate than autografts or synthetic grafts. That theory has yet to be proven however.
Should this line of work prove successful, existing tissue banks could be refitted to create a nationwide supply of therapeutically enhanced tendons for transplant, according to the study authors. Millions of bone and cartilage grafts are already used in orthopaedics, as well as in plastic and general surgery. The banks are made possible by conscientious donors that indicate in their wills, or on their licenses, that their tissue is to be donated upon their death.
Along with Awad, study authors were Patrick Basile, M.D., Tulin Dadali, B.S., Justin Jacobson, M.D., Yasuhiko Nishio, Ph.D., M. Hicham Drissi, Ph.D., Howard Langstein, M.D., David Mitten, M.D., Regis J O'Keefe, M.D., Ph.D., and Edward Schwarz, Ph.D. from the University of Rochester Medical Center as well as Sys Hasslund, Michael Ulrich-Vinther and Kjeld SГёballe from Aarhus University Hospital in Denmark. The team will next seek to determine the mechanisms by which growth factors repair tendons. After that, studies will move into larger animals and humans, potentially within a few years.
"Tendon is very durable," said Regis O'Keefe, M.D., Ph.D., chair of the Department of Orthopaedics and Rehabilitation at the University of Rochester Medical Center, and a study author. "It could conceivably be freeze-dried, thawed and then freeze-dried again without damaging it. It could be left on shelves at tissue banks indefinitely and then shipped long distances. To get it ready for surgery, you would thaw it in a solution containing growth factors, cut it to size on the spot and implant it. While we acknowledge that this work is in mice, that there are differences between species and that more work needs to be done, we believe these results promise practical yet dramatic improvements in reconstructive surgery."
Source: Greg Williams
University of Rochester Medical Center
Drug Combination Slows Progression Of Treatment Resistant Bone Marrow Cancer
Combining a newly formulated drug with one that is already a standard treatment slows the progression of multiple myeloma, an advanced cancer of the bone marrow cells, according to a clinical trial led by a University of North Carolina at Chapel Hill School of Medicine researcher.
The phase III trial included 646 patients from 18 countries with relapsed or refractory multiple myeloma, a condition in which cancerous cells continue to multiply despite treatment. Patients in the trial were randomly assigned to receive the drug bortezomib (Velcade), standard therapy for relapsed multiple myeloma, or a combination of Velcade and Doxil, a chemotherapy drug (doxorubicin) delivered via liposomes, or microscopic fat bubbles.
An interim analysis of study participants who received the combination treatment showed a better response in the combination group than in participants who received standard treatment. The combination group's median time to progression - the time interval between the response to treatment and the time the disease starts to show evidence of growing or recurring - was 9.3 months, while those on Velcade alone progressed after 6.5 months.
The three-month improvement is an important step forward in treatment for multiple myeloma, said Dr. Robert Orlowski, Lenvel Lee Rothrock associate professor in the department of hematology/oncology at the School of Medicine, and a member of the UNC Lineberger Comprehensive Cancer Center.
Orlowski presented the trial's early results at the meeting of the American Society of Hematology in Orlando, Fla. The study was supported by Johnson & Johnson, which owns Ortho Biotech, the maker of Doxil, and also has a financial interest in Velcade.
"The data for time to progression were so positive and encouraging that we decided to announce this information earlier than anticipated so more people could be aware of the benefits of this combination," said Orlowski.
"This study establishes that this combination is one of the standards of care for relapsed, refractory multiple myeloma," Orlowski said. "It does provide some added hope for patients and their families."
The interim analysis also showed an early trend toward increased survival for patients taking the combination treatment, Orlowski said. Additional data on survival and the complete results of this analysis, as well as other factors such as quality of life, will be reported at a later date.
More than 11,000 people in the United States will die of multiple myeloma in 2006, according to the American Cancer Society. Because it affects white blood cells, multiple myeloma suppresses the immune system, so patients can develop sometimes-fatal infections. Other complications include kidney failure, bone pain, anemia, and bleeding.
Doxil is a liposmal version of an older drug, doxorubicin, which means the drug is encapsulated in a microscopic pouch made of lipids, or fats. The formulation seems to produce fewer cardiac side effects and is more convenient to administer.
Orlowski and others first found that doxorubicin and Doxil may complement Velcade in studies of cells in culture, and of mice. "We've been able to take findings from the laboratory and move them on to patients in early, phase I clinical trials, and now in this phase III trial," Orlowski said. "It's an excellent example of how support of basic and translational laboratory research can, in a short time period, result in tangible benefits to patients."
Other investigators were Sen H. Zhuang, Trilok Parekh and Liang Xiu, all of Johnson and & Johnson Pharmaceutical Research & Development, and Jean-Luc Harousseau of University Hospital Hotel-Dieu, Nantes, France.
School of Medicine contact: Leslie Lang
Lineberger Center contact: Dianne Shaw
Contact: L. H. Lang
University of North Carolina School of Medicine
View drug information on Doxil; Velcade.
The phase III trial included 646 patients from 18 countries with relapsed or refractory multiple myeloma, a condition in which cancerous cells continue to multiply despite treatment. Patients in the trial were randomly assigned to receive the drug bortezomib (Velcade), standard therapy for relapsed multiple myeloma, or a combination of Velcade and Doxil, a chemotherapy drug (doxorubicin) delivered via liposomes, or microscopic fat bubbles.
An interim analysis of study participants who received the combination treatment showed a better response in the combination group than in participants who received standard treatment. The combination group's median time to progression - the time interval between the response to treatment and the time the disease starts to show evidence of growing or recurring - was 9.3 months, while those on Velcade alone progressed after 6.5 months.
The three-month improvement is an important step forward in treatment for multiple myeloma, said Dr. Robert Orlowski, Lenvel Lee Rothrock associate professor in the department of hematology/oncology at the School of Medicine, and a member of the UNC Lineberger Comprehensive Cancer Center.
Orlowski presented the trial's early results at the meeting of the American Society of Hematology in Orlando, Fla. The study was supported by Johnson & Johnson, which owns Ortho Biotech, the maker of Doxil, and also has a financial interest in Velcade.
"The data for time to progression were so positive and encouraging that we decided to announce this information earlier than anticipated so more people could be aware of the benefits of this combination," said Orlowski.
"This study establishes that this combination is one of the standards of care for relapsed, refractory multiple myeloma," Orlowski said. "It does provide some added hope for patients and their families."
The interim analysis also showed an early trend toward increased survival for patients taking the combination treatment, Orlowski said. Additional data on survival and the complete results of this analysis, as well as other factors such as quality of life, will be reported at a later date.
More than 11,000 people in the United States will die of multiple myeloma in 2006, according to the American Cancer Society. Because it affects white blood cells, multiple myeloma suppresses the immune system, so patients can develop sometimes-fatal infections. Other complications include kidney failure, bone pain, anemia, and bleeding.
Doxil is a liposmal version of an older drug, doxorubicin, which means the drug is encapsulated in a microscopic pouch made of lipids, or fats. The formulation seems to produce fewer cardiac side effects and is more convenient to administer.
Orlowski and others first found that doxorubicin and Doxil may complement Velcade in studies of cells in culture, and of mice. "We've been able to take findings from the laboratory and move them on to patients in early, phase I clinical trials, and now in this phase III trial," Orlowski said. "It's an excellent example of how support of basic and translational laboratory research can, in a short time period, result in tangible benefits to patients."
Other investigators were Sen H. Zhuang, Trilok Parekh and Liang Xiu, all of Johnson and & Johnson Pharmaceutical Research & Development, and Jean-Luc Harousseau of University Hospital Hotel-Dieu, Nantes, France.
School of Medicine contact: Leslie Lang
Lineberger Center contact: Dianne Shaw
Contact: L. H. Lang
University of North Carolina School of Medicine
View drug information on Doxil; Velcade.
New MRI Techniques May Help Patients Avoid Knee Surgery
Patients with suspected meniscal tears or other injuries to their knees may be able to avoid arthroscopic surgery by
having a 3-Tesla MRI examination instead, two studies together indicate.
Researchers compared 3-Tesla MRI (a newer version of standard MRI) to arthroscopy and found that 3-Tesla MRI had an accuracy
rate of 96% in detecting meniscal tears. The MRI examinations were able to identify 108 of the 112 meniscal tears that were
found when arthroscopic surgery was performed, said Tom Magee, MD, from Neuroskeletal Imaging in Merritt Island, FL, and the
lead author of both studies. There were three cases in which the MRI demonstrated a meniscal tear, not seen on arthroscopy,
Dr. Magee noted. "Because 3-Tesla MRI is accurate, we can confidently examine patients with suspected meniscal tears to
determine if they need surgery immediately or if they might benefit from rehabilitation first to see if their knee injury
heals, possibly avoiding surgery altogether," Dr. Magee said.
3-Tesla MRI can be performed in a unique way (called isotropic imaging) so that the knee can be seen from all angles and
planes then reconstructed three dimensionally as a "virtual arthroscopy." This shows promise not only in detecting meniscal
tears, but ACL tears, MCL injuries and chondral knee injuries as well, Dr. Magee said. "We compared this new technique to
conventional MR knee imaging, and found that both are equally accurate. The benefit to the new technique is that it can be
done faster with less patient motion," Dr. Magee said. In addition, the new technique shows promise in better characterizing
meniscal tears as stable or unstable. "If a tear is stable, the patient may not need surgery; an unstable tear (the tear can
be moved during surgery) requires surgery sooner rather than later," he said. Dr. Magee cautions that MR isotropic imaging is
new and isn't quite ready to replace standard MR knee imaging. However, he is hopeful it could eventually supersede current
knee imaging techniques.
Meniscal tears and other knee injuries are commonly seen in all types of patients, Dr. Magee said.
Dr. Magee will present his studies on May 19 at the American Roentgen Ray Society Annual Meeting in New Orleans, LA.
Contact: Keri Sperry
keriarrs
703-858-4306
American Roentgen Ray Society
arrs
having a 3-Tesla MRI examination instead, two studies together indicate.
Researchers compared 3-Tesla MRI (a newer version of standard MRI) to arthroscopy and found that 3-Tesla MRI had an accuracy
rate of 96% in detecting meniscal tears. The MRI examinations were able to identify 108 of the 112 meniscal tears that were
found when arthroscopic surgery was performed, said Tom Magee, MD, from Neuroskeletal Imaging in Merritt Island, FL, and the
lead author of both studies. There were three cases in which the MRI demonstrated a meniscal tear, not seen on arthroscopy,
Dr. Magee noted. "Because 3-Tesla MRI is accurate, we can confidently examine patients with suspected meniscal tears to
determine if they need surgery immediately or if they might benefit from rehabilitation first to see if their knee injury
heals, possibly avoiding surgery altogether," Dr. Magee said.
3-Tesla MRI can be performed in a unique way (called isotropic imaging) so that the knee can be seen from all angles and
planes then reconstructed three dimensionally as a "virtual arthroscopy." This shows promise not only in detecting meniscal
tears, but ACL tears, MCL injuries and chondral knee injuries as well, Dr. Magee said. "We compared this new technique to
conventional MR knee imaging, and found that both are equally accurate. The benefit to the new technique is that it can be
done faster with less patient motion," Dr. Magee said. In addition, the new technique shows promise in better characterizing
meniscal tears as stable or unstable. "If a tear is stable, the patient may not need surgery; an unstable tear (the tear can
be moved during surgery) requires surgery sooner rather than later," he said. Dr. Magee cautions that MR isotropic imaging is
new and isn't quite ready to replace standard MR knee imaging. However, he is hopeful it could eventually supersede current
knee imaging techniques.
Meniscal tears and other knee injuries are commonly seen in all types of patients, Dr. Magee said.
Dr. Magee will present his studies on May 19 at the American Roentgen Ray Society Annual Meeting in New Orleans, LA.
Contact: Keri Sperry
keriarrs
703-858-4306
American Roentgen Ray Society
arrs
Tricks And Tips For A Safe Halloween
Trick-or-treating, wearing costumes, and carving pumpkins are all part of the Halloween fun for kids of all ages. However, many of these activities also offer potential for injury, the American Academy of Orthopaedic Surgeons (AAOS) suggests that Halloween-goers take the following steps to stay safe.
Potential injuries:
-- Ill-fitting masks and costumes, as well as walking in unfamiliar areas in the dark, can lead to fractures , dislocations, sprains, contusions, abrasions and head trauma from trips and falls.
-- Pumpkin-carving can result in serious lacerations to the hand and also injuries to bones and tendons, if certain precautions are not taken.
"When children get excited about a holiday that involves candy, they may be less cautious than usual," says orthopaedic surgeon Charles Blitzer, MD, spokesperson for the AAOS. "Also, Halloween tends to encourage unruly behavior, so parents and other caregivers need to be especially vigilant to ensure that kids follow basic safety guidelines whether they are pumpkin carving or trick-or-treating."
The AAOS offers the following tips to help ensure an injury-free Halloween:
Pumpkin-carving
-- When carving pumpkins, use specifically designed carving knives, no kitchen knives.
- Carving knives are less likely to get stuck in the thick pumpkin tissue. (Injuries can occur when a carver tries to yank the stuck knife out.)
-- Never let children carve pumpkins.
- Adults carving pumpkins should remember to always cut in small, controlled strokes, away from themselves.
- Carving knives should be kept in a clean, dry, well-lit area.
- Any moisture on the tools, hands, or table can cause the knife to slip, leading to injuries.
-- Should an individual cut a fingertip or hand while carving pumpkins, elevate the hand above the heart and apply direct pressure to the wound with a clean cloth to stop the bleeding.
- If continuous pressure does not slow or stop the bleeding after 15 minutes, an emergency room visit may be necessary.
- If there is any numbness in the fingers and or there is an inability to move the fingers, then the individual should go to the emergency room.
Costumes
-- Halloween costumes should be light and bright, so children are clearly visible to motorists and other pedestrians.
- Trim costumes and bags with reflective tape.
-- Make sure children wear flame-resistant costumes that fit properly.
- Costumes that are too long may cause kids to trip and fall.
-- Children should wear sturdy, comfortable and slip-resistant shoes.
-- Masks and hats can impair a child's vision, so secure hats well and consider using face makeup instead of masks.
Trick-or-Treating
-- When trick-or-treating, children should stay in familiar neighborhoods and be accompanied by an adult at all times.
-- Children must walk on sidewalks and never cut across yards or driveways.
- They should also obey all traffic signals and remain in designated crosswalks when crossing the street.
-- Trick-or-treaters should only approach houses that are well lit.
- Both children and parents should carry flashlights to see and be seen.
-- Consider skipping the door-to-door trick-or-treating and attend a neighborhood Halloween party instead.
-- Examine all treats for tampering or other unsafe conditions before allowing the children to eat them.
Source
American Academy of Orthopaedic Surgeons
Potential injuries:
-- Ill-fitting masks and costumes, as well as walking in unfamiliar areas in the dark, can lead to fractures , dislocations, sprains, contusions, abrasions and head trauma from trips and falls.
-- Pumpkin-carving can result in serious lacerations to the hand and also injuries to bones and tendons, if certain precautions are not taken.
"When children get excited about a holiday that involves candy, they may be less cautious than usual," says orthopaedic surgeon Charles Blitzer, MD, spokesperson for the AAOS. "Also, Halloween tends to encourage unruly behavior, so parents and other caregivers need to be especially vigilant to ensure that kids follow basic safety guidelines whether they are pumpkin carving or trick-or-treating."
The AAOS offers the following tips to help ensure an injury-free Halloween:
Pumpkin-carving
-- When carving pumpkins, use specifically designed carving knives, no kitchen knives.
- Carving knives are less likely to get stuck in the thick pumpkin tissue. (Injuries can occur when a carver tries to yank the stuck knife out.)
-- Never let children carve pumpkins.
- Adults carving pumpkins should remember to always cut in small, controlled strokes, away from themselves.
- Carving knives should be kept in a clean, dry, well-lit area.
- Any moisture on the tools, hands, or table can cause the knife to slip, leading to injuries.
-- Should an individual cut a fingertip or hand while carving pumpkins, elevate the hand above the heart and apply direct pressure to the wound with a clean cloth to stop the bleeding.
- If continuous pressure does not slow or stop the bleeding after 15 minutes, an emergency room visit may be necessary.
- If there is any numbness in the fingers and or there is an inability to move the fingers, then the individual should go to the emergency room.
Costumes
-- Halloween costumes should be light and bright, so children are clearly visible to motorists and other pedestrians.
- Trim costumes and bags with reflective tape.
-- Make sure children wear flame-resistant costumes that fit properly.
- Costumes that are too long may cause kids to trip and fall.
-- Children should wear sturdy, comfortable and slip-resistant shoes.
-- Masks and hats can impair a child's vision, so secure hats well and consider using face makeup instead of masks.
Trick-or-Treating
-- When trick-or-treating, children should stay in familiar neighborhoods and be accompanied by an adult at all times.
-- Children must walk on sidewalks and never cut across yards or driveways.
- They should also obey all traffic signals and remain in designated crosswalks when crossing the street.
-- Trick-or-treaters should only approach houses that are well lit.
- Both children and parents should carry flashlights to see and be seen.
-- Consider skipping the door-to-door trick-or-treating and attend a neighborhood Halloween party instead.
-- Examine all treats for tampering or other unsafe conditions before allowing the children to eat them.
Source
American Academy of Orthopaedic Surgeons
Javelin Pharmaceuticals Completes Patient Enrollment For Second Of Two Pivotal Phase 3 Studies Of Dyloject(TM)
Javelin Pharmaceuticals (AMEX: JAV) announced that it has completed patient enrollment in the second of two US pivotal Phase 3 studies for its injectable pain drug, Dyloject(TM) (diclofenac sodium). This pivotal clinical study evaluated Dyloject in patients with moderate-to-severe postoperative pain following elective orthopedic surgery. A previously completed and successful US pivotal study evaluated Dyloject in patients suffering from moderate-to-severe postoperative pain after elective abdominal surgery. The Company is planning to file a New Drug Application for the treatment of acute postoperative pain in 2009.
Dyloject is being marketed in the UK and Javelin expects to file for marketing approval through the mutual recognition process in a number of additional EU countries during 2009.
About the Orthopedic Efficacy Study
A total of 242 postoperative elective orthopedic surgical patients completed this multicenter, placebo- and comparator-controlled study. They received one of three dose levels of Dyloject(TM) (18.75, 37.5 or 50 mg IV every six hours), one of two dose levels of IV ketorolac (15 or 30 mg every six hours), or IV placebo. Patients with moderate-to-severe pain following elective orthopedic surgery were eligible for treatment for up to 5 days. The primary measure of efficacy was the Sum of Pain Intensity Differences (SPID) as measured on the 0-100 mm Visual Analog Scale (VAS). In this double-blinded study, patients received treatments whose identity was not known either to them or their investigators.
About Dyloject
Dyloject is an injectable formulation of diclofenac in Phase 3 clinical development in the United States and Marketed in the United Kingdom. Diclofenac is a prescription nonsteroidal anti-inflammatory drug ("NSAID") that is widely prescribed to treat post-operative pain due to its combination of effectiveness and tolerability. Dyloject has the potential to provide an attractive alternative to other NSAIDs for the treatment of post-operative pain, and to decrease the need for morphine or other opioids in this setting. There still exists an underserved medical need for a safe and effective injectable NSAID in the hospital setting. In its pivotal UK registration trial, Dyloject's efficacy and safety were shown to be significantly superior to those of the IV formulation of diclofenac currently marketed in the UK. Each dose of the competitive formulation requires buffering, dilution and slow infusion. Dyloject comes ready to use for immediate IV bolus administration, works faster, and according to a recent study, has the potential to save the UK NHS up to GBP 50 per postoperative patient. This pharmacoeconomic benefit, coupled with Dyloject's superior clinical attributes, differentiates Dyloject. Dyloject is presently being marketed in the UK for the treatment of acute moderate-to-severe pain. Subsequent submissions and approvals in other European countries are anticipated through a regulatory strategy following the Mutual Recognition Process.
About Javelin Pharmaceuticals, Inc.
With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. The Company has one marketed drug in the UK and three drug candidates in US Phase 3 clinical development. For additional information about Javelin, please visit the company's website at javelinpharmaceuticals.
Forward Looking Statement
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.
Javelin Pharmaceuticals, Inc.
Dyloject is being marketed in the UK and Javelin expects to file for marketing approval through the mutual recognition process in a number of additional EU countries during 2009.
About the Orthopedic Efficacy Study
A total of 242 postoperative elective orthopedic surgical patients completed this multicenter, placebo- and comparator-controlled study. They received one of three dose levels of Dyloject(TM) (18.75, 37.5 or 50 mg IV every six hours), one of two dose levels of IV ketorolac (15 or 30 mg every six hours), or IV placebo. Patients with moderate-to-severe pain following elective orthopedic surgery were eligible for treatment for up to 5 days. The primary measure of efficacy was the Sum of Pain Intensity Differences (SPID) as measured on the 0-100 mm Visual Analog Scale (VAS). In this double-blinded study, patients received treatments whose identity was not known either to them or their investigators.
About Dyloject
Dyloject is an injectable formulation of diclofenac in Phase 3 clinical development in the United States and Marketed in the United Kingdom. Diclofenac is a prescription nonsteroidal anti-inflammatory drug ("NSAID") that is widely prescribed to treat post-operative pain due to its combination of effectiveness and tolerability. Dyloject has the potential to provide an attractive alternative to other NSAIDs for the treatment of post-operative pain, and to decrease the need for morphine or other opioids in this setting. There still exists an underserved medical need for a safe and effective injectable NSAID in the hospital setting. In its pivotal UK registration trial, Dyloject's efficacy and safety were shown to be significantly superior to those of the IV formulation of diclofenac currently marketed in the UK. Each dose of the competitive formulation requires buffering, dilution and slow infusion. Dyloject comes ready to use for immediate IV bolus administration, works faster, and according to a recent study, has the potential to save the UK NHS up to GBP 50 per postoperative patient. This pharmacoeconomic benefit, coupled with Dyloject's superior clinical attributes, differentiates Dyloject. Dyloject is presently being marketed in the UK for the treatment of acute moderate-to-severe pain. Subsequent submissions and approvals in other European countries are anticipated through a regulatory strategy following the Mutual Recognition Process.
About Javelin Pharmaceuticals, Inc.
With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. The Company has one marketed drug in the UK and three drug candidates in US Phase 3 clinical development. For additional information about Javelin, please visit the company's website at javelinpharmaceuticals.
Forward Looking Statement
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.
Javelin Pharmaceuticals, Inc.
Wearing High Heels And Their Effects On Women's Legs
When it comes to shoes, some women will go through hell for a pair of Jimmy Choos. But what effect does wearing high heels have on our bodies? Clinicians have known for a long time that if you hold a limb in a shortened position over an extended period, the muscles shorten. High-heeled shoes push our heels up, which made Marco Narici from Manchester Metropolitan University wonder whether wearing heels on a regular basis could shorten our calf muscles. According to Narici, there was some anecdotal evidence that something changed because secretaries in the 1950s complained about discomfort when they took their heels off and walked flat-footed. 'I thought it was an experiment which was inadvertently being done by women. What we could do was test high heel wearers to see if we could find some changes in the calf muscle,' says Narici, who publishes his results on 16 July 2010 in the Journal of Experimental Biology.
At that time, Robert Csapo, from the University of Vienna, Austria, was visiting Narici's Active Lifespan Lab, so Narici and Costis Maganaris asked Csapo to test the theory. Placing an advert in the Manchester Evening News asking for volunteers ranging in age from 20 to 50 years who had regularly worn 5В·cm high heels for 2 years or more, Csapo attracted 80 recruits, which he whittled down to a final group of 11 who felt uncomfortable walking without their heels. Then he recruited a second group of women who did not wear high heels and teamed up with Olivier Seynnes to look at the internal workings of both groups' calf muscles.
Measuring the size of the women's calf muscles with MRI, the team found that the calf muscles of the high heel wearers were the same size as those of the women who preferred flat shoes; they hadn't shrunk. 'We were expecting slightly smaller muscle volumes in the high heel wearers because we thought that if the muscle is in a shortened position then you are loading it less and the muscle volume should be smaller,' explains Narici.
Next Csapo and Seynnes used ultrasound to measure the muscle fibre length in the women's calf muscles, and this time they did see a difference. The high heel wearers' muscle fibres were 13% shorter than those of the women who wore flat shoes. 'This confirmed the hypothesis,' says Narici, 'because when you place the muscle in a shorter position, the fibres become shorter.' However, by shortening the fibres, the muscles would have to contract more to shorten by the same length, and if this was the case the high heel fans' calf muscles could no longer function optimally and thus would produce less force than the flat shoe wearer's calf muscles. Had the shortened muscle fibres made it more difficult for high heel addicts to walk efficiently?
The team turned their attention to the tendons that attach the calf muscle to the heel. Scanning with MRI, the team could see that the Achilles' tendon was the same length in the two groups of women. The tendon had not lengthened to compensate for the shorter calf muscle. However, the high heel fans' tendons were much thicker and stiffer than the flat shoe wearers'. Narici and his team realised that by thickening and stiffening, the Achilles' tendon compensates for the shortened muscle fibres in the calf muscle, allowing the fashion addicts' calf muscles to function optimally as they walk, but causing discomfort when walking on flat feet because the tendon cannot stretch sufficiently.
So should women give up wearing high heels? Narici doesn't think so, but suggests that fashion addicts may want to try stretching exercises to avoid soreness when they kick off their heels at the end of the day.
Reference:
Csapo, R., Maganaris, C. N., Seynnes, O. R. and Narici, M. V. (2010). On muscle, tendon and high heels. J. Exp. Biol. 213, 2582-2588.
Source:
The Company of Biologists
At that time, Robert Csapo, from the University of Vienna, Austria, was visiting Narici's Active Lifespan Lab, so Narici and Costis Maganaris asked Csapo to test the theory. Placing an advert in the Manchester Evening News asking for volunteers ranging in age from 20 to 50 years who had regularly worn 5В·cm high heels for 2 years or more, Csapo attracted 80 recruits, which he whittled down to a final group of 11 who felt uncomfortable walking without their heels. Then he recruited a second group of women who did not wear high heels and teamed up with Olivier Seynnes to look at the internal workings of both groups' calf muscles.
Measuring the size of the women's calf muscles with MRI, the team found that the calf muscles of the high heel wearers were the same size as those of the women who preferred flat shoes; they hadn't shrunk. 'We were expecting slightly smaller muscle volumes in the high heel wearers because we thought that if the muscle is in a shortened position then you are loading it less and the muscle volume should be smaller,' explains Narici.
Next Csapo and Seynnes used ultrasound to measure the muscle fibre length in the women's calf muscles, and this time they did see a difference. The high heel wearers' muscle fibres were 13% shorter than those of the women who wore flat shoes. 'This confirmed the hypothesis,' says Narici, 'because when you place the muscle in a shorter position, the fibres become shorter.' However, by shortening the fibres, the muscles would have to contract more to shorten by the same length, and if this was the case the high heel fans' calf muscles could no longer function optimally and thus would produce less force than the flat shoe wearer's calf muscles. Had the shortened muscle fibres made it more difficult for high heel addicts to walk efficiently?
The team turned their attention to the tendons that attach the calf muscle to the heel. Scanning with MRI, the team could see that the Achilles' tendon was the same length in the two groups of women. The tendon had not lengthened to compensate for the shorter calf muscle. However, the high heel fans' tendons were much thicker and stiffer than the flat shoe wearers'. Narici and his team realised that by thickening and stiffening, the Achilles' tendon compensates for the shortened muscle fibres in the calf muscle, allowing the fashion addicts' calf muscles to function optimally as they walk, but causing discomfort when walking on flat feet because the tendon cannot stretch sufficiently.
So should women give up wearing high heels? Narici doesn't think so, but suggests that fashion addicts may want to try stretching exercises to avoid soreness when they kick off their heels at the end of the day.
Reference:
Csapo, R., Maganaris, C. N., Seynnes, O. R. and Narici, M. V. (2010). On muscle, tendon and high heels. J. Exp. Biol. 213, 2582-2588.
Source:
The Company of Biologists
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