Study Questions Safety, Effectiveness Of Total Knee Replacement

Another study questions the safety and efficacy of total knee replacements. Researchers say that additional data is needed on not just the devices’ safety and efficacy, but on patient satisfaction, as well.

Total knee replacement surgery involves complete replacement of the knee joint with an artificial joint, typically because of arthritis, said the BBC. Researchers, writing in the journal Lancet, say that the array of knee implants had “proliferated” without complete testing of the devices, noting that the UK’s National Joint Registry was a “key source” of data, wrote the BBC.

Although the researchers did not identify a health risk associated with total knee replacements, they underscored the importance of creating “long-term monitoring” for the implants, said the BBC. Professor Andrew Carr, one of the researchers and from the University of Oxford, told the BBC, “We’re not sitting on a metal-on-metal situation, but there could be something not being picked up as there are not the processes going on for monitoring [total knee replacements].”

According to Professor Carr, the amount of available implants “substantially proliferated” with 30-40 models currently available from no less than 15 manufacturers. Professor Carr pointed out that approval was typically received “often with little or no evidence of effectiveness or cost-effectiveness,” adding that regulations must be more stringent and “more along the lines of introducing new drugs,” said the BBC.

The Medicines and Healthcare products Regulatory Agency (MHRA) said some 80,000 knee joint replacements were done in the UK in 2010 and safety data was collected on all of them. MHRA clinical director, Dr. Susanne Ludgate, told the BBC, “Since April 2003, all knee joint replacement operations in England and Wales have been recorded in the NJR.”

Research professor and medical director of Arthritis Research UK, Alan Silman, told the BBC, “Given the current concerns raised by the metal-on-metal hip replacements—although there is no evidence that there are similar implications for knee replacements—it’s appropriate to take stock of the advantages and costs of knee joint replacement. ”

In the U.S., knee replacements have been the focus of a number of issues. We recently wrote that another component in Zimmer’s NexGen knee replacement line has been named in a personal injury lawsuit.

Last month, a Tennessee woman filed a federal complaint alleging she suffered serious bodily injury and harm following total knee Arthroplasty with the Zimmer NexGen LPS-Flex femoral component. That lawsuit, filed by the national law firm of Parker Waichman LLP on February 17, 2012 in U.S. District Court for the Middle District of Tennessee, Nashville Division (CV No. 3:12-cv-00189), is just one of many filed nationwide involving various NexGen Knee implant components, including the Zimmer NexGen CR-Flex femoral components, Zimmer NexGen MIS tibial components, and Zimmer NexGen LPS-Flex femoral components. All the lawsuits allege that plaintiffs experienced problems following knee replacement surgery resulting from design defects with the Zimmer NexGen components. In many cases, painful revision surgeries were needed.

Last August, all federal NexGen Knee Replacement component lawsuits filed in federal courts were centralized in a multidistrict litigation (MDL) in U.S. District Court for the Northern District of Illinois.

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