(Press-News.org) Contact information: Emma Dickinson
edickinson@bmj.com
44-020-738-36529
BMJ-British Medical Journal
Nearly 8 percent of hip implants not backed by safety evidence
Current device regulation process 'seems to be entirely inadequate,' warn researchers
The researchers say the current regulation process "seems to be entirely inadequate" and they call for a revised system for introducing new orthopaedic devices.
The high failure rate of some metal-on-metal hip replacements has highlighted the need for an adequate evidence base for orthopaedic implants. Many implants are available to orthopaedic surgeons, but it is not known how many of these have evidence of clinical effectiveness to support their use.
So researchers based at the University of Oxford set out to establish the number of hip replacement joints that have no readily available evidence of clinical effectiveness to support their use – and how many are being implanted in clinical practice.
Using data from the National Joint Registry (NJR) of England and Wales, they identified implants used in hip replacement surgery in 2011 that were rated "unclassified" or "pre-entry" by the Orthopaedic Data Evaluation Panel (ODEP) – the body that rates implants according to levels of evidence.
Implants termed "unclassified" have had no evidence submitted by the manufacturers, while "pre-entry" products have less than three years of evidence. Yet many are widely available for implantation by an orthopaedic surgeon.
The team then reviewed the medical literature to establish the level of evidence available for these implants.
The review showed that 10,402 (7.6%) of the 136,593 components used in primary hip replacements in 2011 were implanted without readily identifiable evidence of clinical effectiveness. These comprised 157 cemented stems (0·5% of those implanted), 936 uncemented stems (2.8%), 1,732 cemented cups (7.1%), and 7,577 uncemented cups (17.1%).
This is of great concern, say the authors, "particularly in light of the widespread publicity surrounding recent safety problems with regard to some resurfacing and other large diameter metal-on-metal joint replacements."
This is also likely to be an underestimation of the true problem, "as much of the evidence that does exist for the other unrated prostheses is of low quality or relates to short-term outcomes only," they add.
They suspect that the paucity of good quality evidence in this area may be related to the rapid expansion in the number of devices introduced onto the market during the past two decades, as demand for hip replacement surgery increases worldwide, and the difficulty of conducting high quality randomised controlled trials with orthopaedic implants.
"This study shows that the need still exists for an improved and more rigorous approach to regulation of devices to avoid devices with no available evidence being used in a widespread and uncontrolled manner," they conclude.
In an accompanying editorial, researchers at Harvard Medical School argue that "the ability of manufacturers to promote devices or drugs that are authorized by regulators for widespread use but that do not have rigorous pre-approval data should be restricted."
They add: "physicians who adopt new technologies that have little or no evidence of superiority over existing products need to be educated about the implications of their choices. They should also ensure that their patients know about the benefits and risks of the new - but often unproved - medical devices that they are receiving."
### END
Nearly 8 percent of hip implants not backed by safety evidence
Current device regulation process 'seems to be entirely inadequate,' warn researchers
2013-12-20
ELSE PRESS RELEASES FROM THIS DATE:
Government's voluntary approach to improving hospital food is not working, argues expert
2013-12-20
Government's voluntary approach to improving hospital food is not working, argues expert
3 out of 5 hospital meals found to contain more salt than a Big Mac
In an article published on bmj.com today, she says the government has wasted more than £54 million ...
Many people with diabetes still lose vision, despite availability of vision-sparing treatment
2013-12-20
Many people with diabetes still lose vision, despite availability of vision-sparing treatment
Researchers blame lack of education about advances in preventive care
Despite recent advances in prevention and treatment of most vision loss attributed to diabetes, ...
Salty surprise -- ordinary table salt turns into 'forbidden' forms
2013-12-20
Salty surprise -- ordinary table salt turns into 'forbidden' forms
High-pressure X-ray experiments violate textbook rules of chemistry
This news release is available in German. High-pressure experiments with ordinary table salt have produced ...
The black-white infant mortality gap: Large, persistent and unpredictable
2013-12-20
The black-white infant mortality gap: Large, persistent and unpredictable
EAST LANSING, Mich. — The unobservable factors that underpin the infant mortality gap between blacks and whites have persisted for more than 20 years and now appear to play a larger role than ...
Biologists find clues to a parasite's inconsistency
2013-12-20
Biologists find clues to a parasite's inconsistency
CAMBRIDGE, MA -- Toxoplasma gondii, a parasite related to the one that causes malaria, infects about 30 percent of the world's population. Most of those people don't even know they are infected, but ...
Electron 'antenna' tunes in to physics beyond Higgs
2013-12-20
Electron 'antenna' tunes in to physics beyond Higgs
Though it was hailed as a triumph for the "Standard Model" of physics – the reigning model of fundamental forces and particles – physicists were quick to emphasize that last year's discovery of the Higgs boson still ...
Opposing phenomena possible key to high-efficiency electricity delivery
2013-12-20
Opposing phenomena possible key to high-efficiency electricity delivery
The coexistence of two opposing phenomena might be the secret to understanding the enduring mystery in physics of how materials heralded as the future of powering our homes and communities ...
Electron's shapeliness throws a curve at supersymmetry
2013-12-20
Electron's shapeliness throws a curve at supersymmetry
A small band of particle-seeking scientists at Yale and Harvard has established a new benchmark for the electron's almost perfect roundness, raising doubts about certain theories that predict what lies beyond physics' ...
Salt under pressure is not NaCl
2013-12-20
Salt under pressure is not NaCl
In the very beginning of the school chemistry course, we are told of NaCl as an archetypal ionic compound. Being less electronegative, sodium loses its electron to chlorine, which, following the "octet rule", thus acquires the ...
Amino acid's increase is suspected in diabetes
2013-12-20
Amino acid's increase is suspected in diabetes
Research examines effects of lower and higher tyrosine levels
SAN ANTONIO (Dec. 19, 2013) — Elevated levels of an amino acid, tyrosine, alter development and longevity in animals and may ...
LAST 30 PRESS RELEASES:
UMass Amherst Nursing Professor Emerita honored as ‘Living Legend’
New guidelines aim to improve cystic fibrosis screening
Picky eaters by day, buffet by night: Butterfly, moth diets sync to plant aromas
Pennington Biomedical’s Dr. Leanne Redman honored with the E. V. McCollum Award from the American Society for Nutrition
CCNY physicists uncover electronic interactions mediated via spin waves
Researchers’ 3D-printing formula may transform future of foam
Nurture more important than nature for robotic hand
Drug-delivering aptamers target leukemia stem cells for one-two knockout punch
New study finds that over 95% of sponsored influencer posts on Twitter were not disclosed
New sea grant report helps great lakes fish farmers navigate aquaculture regulations
Strain “trick” improves perovskite solar cells’ efficiency
How GPS helps older drivers stay on the roads
Estrogen and progesterone stimulate the body to make opioids
Dancing with the cells – how acoustically levitating a diamond led to a breakthrough in biotech automation
Machine learning helps construct an evolutionary timeline of bacteria
Cellular regulator of mRNA vaccine revealed... offering new therapeutic options
Animal behavioral diversity at risk in the face of declining biodiversity
Finding their way: GPS ignites independence in older adult drivers
Antibiotic resistance among key bacterial species plateaus over time
‘Some insects are declining but what’s happening to the other 99%?’
Powerful new software platform could reshape biomedical research by making data analysis more accessible
Revealing capillaries and cells in living organs with ultrasound
American College of Physicians awards $260,000 in grants to address equity challenges in obesity care
Researchers from MARE ULisboa discover that the European catfish, an invasive species in Portugal, has a prolonged breeding season, enhancing its invasive potential
Rakesh K. Jain, PhD, FAACR, honored with the 2025 AACR Award for Lifetime Achievement in Cancer Research
Solar cells made of moon dust could power future space exploration
Deporting immigrants may further shrink the health care workforce
Border region emergency medical services in migrant emergency care
Resident physician intentions regarding unionization
Healthy nutrition and physical lifestyle choices lower cancer mortality risk for survivors, new ACS study finds
[Press-News.org] Nearly 8 percent of hip implants not backed by safety evidenceCurrent device regulation process 'seems to be entirely inadequate,' warn researchers