Featured Research

from universities, journals, and other organizations

Nearly eight percent of hip implants not backed by safety evidence

Date:
December 20, 2013
Source:
BMJ-British Medical Journal
Summary:
Almost 8 percent of all implants used in hip replacement surgery have no readily available evidence relating to their safety or effectiveness, finds a study published on bmj.com today.

The researchers say the current regulation process "seems to be entirely inadequate" and they call for a revised system for introducing new orthopedic devices.

The high failure rate of some metal-on-metal hip replacements has highlighted the need for an adequate evidence base for orthopedic implants. Many implants are available to orthopedic 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 orthopedic 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 orthopedic 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 (05% 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 randomized controlled trials with orthopedic 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."


Story Source:

The above story is based on materials provided by BMJ-British Medical Journal. Note: Materials may be edited for content and length.


Journal Reference:

  1. F. Kynaston-Pearson, A. M. Ashmore, T. T. Malak, I. Rombach, A. Taylor, D. Beard, N. K. Arden, A. Price, D. Prieto-Alhambra, A. Judge, A. J. Carr, S. Glyn-Jones. Primary hip replacement prostheses and their evidence base: systematic review of literature. BMJ, 2013; 347 (dec19 2): f6956 DOI: 10.1136/bmj.f6956

Cite This Page:

BMJ-British Medical Journal. "Nearly eight percent of hip implants not backed by safety evidence." ScienceDaily. ScienceDaily, 20 December 2013. <www.sciencedaily.com/releases/2013/12/131220120849.htm>.
BMJ-British Medical Journal. (2013, December 20). Nearly eight percent of hip implants not backed by safety evidence. ScienceDaily. Retrieved July 24, 2014 from www.sciencedaily.com/releases/2013/12/131220120849.htm
BMJ-British Medical Journal. "Nearly eight percent of hip implants not backed by safety evidence." ScienceDaily. www.sciencedaily.com/releases/2013/12/131220120849.htm (accessed July 24, 2014).

Share This




More Health & Medicine News

Thursday, July 24, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Idaho Boy Helps Brother With Disabilities Complete Triathlon

Idaho Boy Helps Brother With Disabilities Complete Triathlon

Newsy (July 23, 2014) An 8-year-old boy helped his younger brother, who has a rare genetic condition that's confined him to a wheelchair, finish a triathlon. Video provided by Newsy
Powered by NewsLook.com
Thousands Who Can't Afford Medical Care Flock to Free US Clinic

Thousands Who Can't Afford Medical Care Flock to Free US Clinic

AFP (July 23, 2014) America may be the world’s richest country, but in terms of healthcare, the World Health Organisation ranks it 37th. Thousands turned out for a free clinic run by "Remote Area Medical" with a visit from the Governor of Virginia. Duration: 2:40 Video provided by AFP
Powered by NewsLook.com
Stone Fruit Listeria Scare Causes Sweeping Recall

Stone Fruit Listeria Scare Causes Sweeping Recall

Newsy (July 22, 2014) The Wawona Packing Company has issued a voluntary recall on the stone fruit it distributes due to a possible Listeria outbreak. Video provided by Newsy
Powered by NewsLook.com
Huge Schizophrenia Study Finds Dozens Of New Genetic Causes

Huge Schizophrenia Study Finds Dozens Of New Genetic Causes

Newsy (July 22, 2014) The 83 new genetic markers could open dozens of new avenues for schizophrenia treatment research. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins