PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

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
(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


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:

McGill discovery sheds new light on autism, intellectual disabilities

Cellular changes occur even below the hexavalent chromium limit

Study suggests a new way to curb social media’s body image toll

Plant doctor: An AI system that watches over urban trees without touching a leaf

Study tracks chromium chemistry in irradiated molten salts

Scientists: the beautiful game is a silver bullet for global health

Being physically active, even just a couple of days a week, may be key to better health

High-fat diet promote breast cancer metastasis in animal models

A router for photons

Nurses and AI collaborate to save lives, reduce hospital stays

Multi-resistance in bacteria predicted by AI model

Tinker Tots: A citizen science project to explore ethical dilemmas in embryo selection

Sensing sickness

Cost to build multifamily housing in California more than twice as high as in Texas

Program takes aim at drinking, unsafe sex, and sexual assault on college campuses

Inability to pay for healthcare reaches record high in U.S.

Science ‘storytelling’ urgently needed amid climate and biodiversity crisis

KAIST Develops Retinal Therapy to Restore Lost Vision​

Adipocyte-hepatocyte signaling mechanism uncovered in endoplasmic reticulum stress response

Mammals were adapting from life in the trees to living on the ground before dinosaur-killing asteroid

Low LDL cholesterol levels linked to reduced risk of dementia

Thickening of the eye’s retina associated with greater risk and severity of postoperative delirium in older patients

Almost one in ten people surveyed report having been harmed by the NHS in the last three years

Enhancing light control with complex frequency excitations

New research finds novel drug target for acute myeloid leukemia, bringing hope for cancer patients

New insight into factors associated with a common disease among dogs and humans

Illuminating single atoms for sustainable propylene production

New study finds Rocky Mountain snow contamination

Study examines lactation in critically ill patients

UVA Engineering Dean Jennifer West earns AIMBE’s 2025 Pierre Galletti Award

[Press-News.org] Nearly 8 percent of hip implants not backed by safety evidence
Current device regulation process 'seems to be entirely inadequate,' warn researchers