This article is more than 5 years old. Information may no longer be current.

More data on long-term safety, effectiveness of implants for TKR may be needed

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

According to a seminar published online in The Lancet, there is little or no evidence on the safety or cost-effectiveness for numerous types of knee replacements on the market — and a lack of reliable information comparing patient-reported outcomes with different implants and surgical techniques may prevent surgeons from achieving the best outcomes.

“The regulatory framework for new implants varies worldwide, but has been generally much less rigorous than for new drugs,” author Andrew Carr, FMedSci, stated in a Lancet news release. “Currently, proof of safety of implanted materials is all that is required prior to approval for clinical use, rather than evidence for clinical effectiveness. Widespread surveillance of existing implants is urgently needed alongside the carefully monitored introduction of new implant designs as part of well conducted large-scale randomized trials.”

According to the release, while national joint replacement registries are among the few sources of comparative information, the continuous introduction of new implant designs means these registries need to always monitor outcomes of new implants and technologies.

“There is increasing evidence to suggest that published clinical trial outcomes for individual knee replacements report better results than those available from registries,” Carr stated in the release. “Without high-quality, unbiased and reliable information, surgeons cannot make informed decisions about how to achieve the best outcome in each clinical situation.”

In the release, Carr suggested improving patient selection for surgery and targeting resources to new treatment strategies avoiding the need for major surgery — such as the management of arthritis at earlier stages and reversal or deceleration of disease progression — to reduce the demand for replacement surgery.

“Patients should be reassured that knee replacement surgery has proved to be one of the outstanding success stories of modern medicine and has resulted in significant quality of life gains for people with end-stage arthritis,” Carr stated in the release.

Reference:

• Carr AJ, Robertsson O, Graves S, et al. Knee replacement. Lancet. 2012. doi:10.1016/S0140-6736(11)60752-6