Monday, January 28. 2008
Link
http://www.uwhealth.org/page.asp?contentid=11934
MADISON - Among baby boomers and active younger patients, interest in
Hip Resurfacing
surgery, a bone-sparing procedure available for the last year at UW Hospital
and Clinics, continues to soar. It's easy to understand why. Patients with resurfaced hips are enjoying
increased range of motion and decreased dislocation, making it possible for
them to return to a fully active lifestyle. Unlike traditional
Total Hip
Replacement, a procedure in which surgeons cut the neck of the femur and
remove the femoral head, resurfacing a hip involves removing the cartilage
at the end of the femur, placing a metal cap over the top, and repositioning
it in a metal socket. For patients in their 30s and 40s, resurfacing
provides the important benefit of preserving bone in the event a future hip
revision surgery is needed. At UW Health, three fellowship-trained surgeons - Dr.
John Heiner,
Dr. Richard Illgen and
Dr. Matthew Squire - perform the procedure. The surgeons caution that hip resurfacing isn't for everybody. Younger
patients with good bone quality are the best candidates for the procedure;
patients with poor bone quality or kidney problems are not. Women are also
less likely to be candidates for hip resurfacing if they're planning to have
children or suffer from dysplasia. In countries like Australia, where hip resurfacing has been the standard of
care for several years, approximately 15 percent of patients needing a hip
surgery to manage severe arthritis qualified as good candidates for hip
resurfacing. Even though interest in hip resurfacing is high, the surgeons
expect those numbers to be similar for U.S. patients. "To get good outcomes, it's important to have experienced surgeons and
physical therapists to help patients navigate the recovery process and
return to an active lifestyle," says Dr. Illgen. "That is one of our
strengths."
Four different state-of-the-art rehabilitation facilities in the Madison
area make a huge difference in recovery for patients, as does an aggressive,
sensible post-rehabilitation protocol that focuses on a team-based approach
involving both doctors and physical therapists.
"The way we're approaching this is radically different than when we were
doing total hip replacements a few years ago," notes Dr. Illgen. "Then, we
weren't talking about patients asking, 'Can I go back to playing tennis and
biking?' Now we are, and we couldn't be happier about it."
As the word about hip resurfacing continues to spread, orthopedic surgeons
at UW Health are already looking at the next evolution of the surgery:
computer-assisted hip resurfacing.
"We already have the technology on hand here in the hospital," says Dr.
Squire. "It makes sense for us to explore that."
For more information about
Hip Resurfacing
at UW Hospital and Clinics, call (608) 263-4069
Monday, January 28. 2008
Link
http://health.ucsd.edu/news/2007/5_1_Ball.htm
Date: May 01, 2007
Surgery Attractive Alternative for Athletes, Now Available at UCSD Medical
Center
The anthem of “work hard, play hard” is impossible to sustain when your joints
just don’t work. Increasingly, highly active men and women are finding a need
for hip surgery at an earlier age.
“It’s hard to say why my hips gave out,” said David Nassi, 55, a real estate
agent in Solana Beach. “I was an avid marathoner, often running 70 miles per
week. But even after I stopped running, the pain gradually got worse and worse.
I couldn’t even lift my foot.”
Nassi fits a growing demographic of patients needing surgery to replace worn out
hip joints. Fortunately, hip resurfacing is an alternative to total hip
replacement.
“Historically, patients under the age of 60 have a higher early failure rate
with total hip replacement. These patients are often very active and put lots of
hard miles on the hip,” said Scott Ball, M.D., orthopedic surgeon at UCSD
Medical Center.
During total hip replacement, the head and neck of the femur, or thigh bone, are
entirely removed and a stem is placed into the shaft of the femur with a new
ball on top of the stem. In comparison, with resurfacing, the head and hip
socket are just reshaped and resurfaced with implants. The technology was
approved by the FDA in May 2006. The system replaces worn ball-and-socket
surfaces in the joint with smooth, durable high carbide cobalt chrome surfaces.
One of the biggest advantages of hip resurfacing is that the bone is preserved
and continues to bear weight which helps to maintain bone strength. Saving this
bone is important in young people because they may need surgery in the future.
“Many patients self-select for the procedure because they want to continue
jogging, skiing, and surfing activities which have traditionally been forbidden
with total hip replacements. Despite the fact that these patients are returning
to high level activities, the device appears to be withstanding the increased
stresses,” said Ball.
Early studies from implant manufacturers estimate the average success rate for
resurfacing over the first 5 to 10 years is around 95% to 98%. In other words,
only about 2% to 5% of patients need a total hip replacement in the first 5 to
10 years after resurfacing. If the device fails, patients can still be treated
with a total hip replacement and expect an excellent outcome.
“It’s phenomenal. Since my surgery I have been able to return to cycling and
swimming,” said Nassi. “This is the first time in 7 years I have been pain free.
I can even do all the things that I used to take for granted like crossing my
legs to put my socks on. Give me five months, I’ll be running again.”
According to the American Academy of Orthopedic Surgeons, more than 400,000
total or partial hip replacements are performed every year. This number is
expected to increase as the population ages and life spans increase.
Monday, January 28. 2008
New Promising Data on S&N’s BIRMINGHAM HIP™ System
Link
http://www.ryortho.com/NEWSSHORTS/volume3/issue39/12-10-07-NS-New.htm
By Elizabeth Hofheinz, MEd, MPH December 10, 2007
No more wondering Down Under. The data is in. Smith & Nephew, Inc.’s
Orthopaedic Reconstruction business is announcing the release of positive
six-year clinical data by the Australian Orthopaedic Association National Joint
Replacement Registry on the company’s BIRMINGHAM HIP Resurfacing System (BHR™).
According to the company, the BHR, which has now been implanted in nearly 80,000
patients in 26 countries, conserves more of a patient’s bone than a traditional
hip replacement, enabling younger, more active patients to undergo hip
replacement surgery while preserving all future surgery options, including a
primary hip replacement. The design of the BIRMINGHAM HIP Resurfacing System
also offers patients a reduced risk of dislocation. The report revealed that the
BHR device has the highest hip resurfacing system survivability rate among all
of its established competitors for which data had been collected.
Included in the Australian report was the following information:
Since the inception of the registry, the BIRMINGHAM HIP Resurfacing System has
been the overwhelming choice of patients—over 75% of resurfacing procedures have
used the BHR device.
According to the registry, hip resurfacing accounts for 7.9% of all primary
hip replacements.
Commenting in the news release was Joseph DeVivo, President of Smith &
Nephew Orthopaedic Reconstruction: “We are extremely pleased with the
Registry’s results. The report once again highlights the ability of the
BIRMINGHAM HIP Resurfacing System to help people maintain the most active
and healthy lifestyle possible. The BIRMINGHAM HIP Resurfacing System lets
active people live the life they love and continue to pursue their passions.
The long-term clinical data available clearly demonstrates the benefits of
the BIRMINGHAM HIP Resurfacing System, which is the gold standard for
resurfacing technology in the world and a significant addition to our
reconstructive product portfolio in the United States.”
The Registry evaluates the timing and reasons for revision surgery as well
as mortality rates, and it measures the success rates of products and
procedures across Australia. This year’s report is based on the analysis of
332,700 hip and knee procedures undertaken in 271,188 patients from
September 1999 through December 31, 2006.
According to the company, the study is highly regarded for its
comprehensiveness and accuracy because the Registry is able to obtain a
near-complete set of data relating to hip and knee joint replacement for an
entire country. The Registry receives information from all public and
private hospitals undertaking joint replacement. Using a strict validation
process and following retrieval of unreported records and checking of
unmatched data, the initial validation for the 2005/6 Registry data resulted
in over 96% of Registry records verified against health department data.
Thursday, January 24. 2008
Link
http://www.iol.co.za/index.php?set_id=1&click_id=13&art_id=vn20060821014255934C837090
By Karen
Breytenbach
Two American orthopaedic surgeons have been taught
an innovative hip surgery technique by a local
surgeon.
Leith Stewart, an orthopaedic surgeon at Claremont
Hospital (South Arfrica), last week demonstrated the Birmingham Hip
Resurfacing (BHR) procedure to his guests, Ian
Kovack from Kansas and Donald Polakoff from New
Jersey.
One patient was a professional golfer in her 30s and
the other an active woman in her 60s. Both were told
they would be up and on crutches within two days,
instead of six weeks if normal surgery was done.
Both will also be able to drive, cycle and swim
within three weeks instead of six.
Stewart, an avid cyclist and snowboarder, has been
performing the procedure for six years. He had a BHR
performed on his left hip about four years ago, with
great success.
Since 1997 the procedure, developed by two British
surgeons as a bone conserving alternative to total
hip replacement, has been used on about 51 000
patients in the UK, Germany, Australia and South
Africa.
The procedure was only recently approved by the US
Food and Drug Administration, on condition that
surgeons receive training.
While total hip replacement has yielded good results
in elderly inactive people, the procedure has been
less successful in young and active people, who
respond better to resurfacing.
Hip resurfacing is the replacement of the cartilage
covering the surfaces of the ball at the end of the
thigh bone (femur) and the cup-shaped cavity (acetabulum)
into which it fits, with cobalt chrome, into which
bone grows" in weeks".
Friday, January 18. 2008
FDA to Stryker: Fix hip implant flaws
Link
CNBC
By LINDA A. JOHNSON updated 5:48 p.m. ET, Wed., Jan. 16, 2008
TRENTON, N.J. - Federal regulators have ordered medical device maker Stryker
Corp. to fix a host of long-standing problems in its manufacturing of hip
replacement parts that have triggered multiple patient complaints and forced
some to have follow-up surgeries. Stryker shares fell almost 2 percent.
The U.S. Food and Drug Administration told Kalamazoo, Mich.-based Stryker in a
letter that it was aware that the company has received patient complaints since
January 2005 about a range of problems, including improper fitting of hip
implants that caused bone fractures. Patients also have complained about pain,
difficulty walking and "squeaky" joins, and some have had pieces of implant
parts break off or wear down unevenly.
The six-page warning letter was prepared after FDA officials spent six weeks
last summer inspecting the company's orthopedics division headquarters in
Mahwah, N.J., which houses manufacturing operations, research and development
and administrative offices.
The letter discusses deficiencies found during those inspections and repeatedly
states that four company responses on those issues, sent between Aug. 1 and Nov.
2, were inadequate for a variety of reasons.
"Your firm has failed to perform corrective and preventive actions in order to
prevent the recurrence of nonconforming product or other quality problems," the
Nov. 28 letter states repeatedly.
FDA said in the letter that if Stryker does not correct the violations promptly,
FDA can act without notice and seize property, levy fines and seek injunctions.
The letter also notes that the FDA will not approve sale of certain new Stryker
medical devices until the violations are fixed and that it will notify federal
agencies about the warning letter, so they can consider it when awarding
contracts.
A heavily redacted version of the letter was posted Tuesday on the agency's Web
site.
FDA noted that some parts of the plant were found to be contaminated with
disease-causing germs, including "clumps and clusters" of a form of
Staphylococcus bacteria.
"Your firm has not identified the root causes of the microorganism contamination
and has not executed corrective and preventive action to prevent recurrence,"
the letter states.
Stryker officials declined an interview request from The Associated Press
Wednesday, but provided a prepared statement.
"We take these matters very seriously and are committed to developing,
manufacturing and marketing medical products that are safe and effective and
that comply with applicable laws and regulations," it said. "We have been
working diligently for the past several months to respond to the FDA and will
continue to work closely with them to address these matters."
Stryker was among five companies, which together provide nearly all replacement
hips and knees in the U.S. market, that in September agreed to pay $310 million
and accept federal monitors to settle allegations they gave doctors kickbacks to
use their products.
Stryker shares fell $1.36, or 1.9 percent, to $69.75 in trading Wednesday.
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