Study: Newer Joint Replacements Require More RevisionsSep 3, 2008 | Parker Waichman LLP
It seems that newer medical techniques that are used in hip and knee replacements require revisions at a greater rate that older, established methods. British researchers report that one in about 75 people required repeat hip and knee replacements in the three years following the original procedure. The study was published in the journal PLoS Medicine.
The revision rates were even higher for patients who had new surgical techniques called hip resurfacing and unicondylar knee replacements. Researchers said that these findings are raising concerns about the procedures. "On the basis of our data, consideration should be given to using hip resurfacing only in male patients and unicondylar knee replacement in elderly patients," Jan van der Meulen of the London School of Hygiene and Tropical Medicine and colleagues wrote.
The research involved an analysis of about 170,000 procedures that took place between 2003 and 2006. Nearly half of all of these surgeries were performed in England during this time frame and experienced an overall revision rate of 1.4 percent, which is about one in 75 people. Meanwhile, hip resurfacing, which is a newer technique in which doctors replace just the surface of the femur instead of the entire joint, saw a revision rate of 2.6 percent, the study found. Also, unicondylar knee replacement—which is a procedure in which the surgeon only replaces one side of the knee joint—saw a revision rate of 2.8 percent, van der Meulen said.
The results match findings from other countries that also reflected higher revision rates for the new procedures, according to van der Meulen. The new surgeries offer benefits because recovery time can be shorter because only a part of the joint is replaced, van der Meulen added. "That is an observation that is seen around the world," he said. "Our registry is the largest in the world, which allows us to look at the most recent results.
Hip and knee replacements are among the most frequently performed surgeries, and medical device makers like Britain's Smith & Nephew and U.S.-based Stryker Corp have looked to new techniques given the increasing aging population. van der Meulen noted that the researchers did not review or product types.
Earlier last month, we reported that the Food and Drug Administration (FDA) was in the early stages of developing a program to create a national surveillance registry for orthopedic device implants, enabling the FDA to look into independent public and private registries from which claim information would be fed into a central agency-regulated network.
According to an FDA spokesman, orthopedic device manufacturers would benefit from the program because it would “offer more timely, comprehensive assessment of the ‘real world’ experience of their devices and an alternative means to conduct mandated post-approval studies.” Advocates argue that such a system would quickly alert doctors and federal regulators to devices with high failure rates, possibly sparing tens of thousands of patients from severe, painful injuries. One such examples is with the hundreds of patients who received the Zimmer Durom Cup hip implants in the U.S. and experienced serious adverse reactions.