January 19, 2013 — The Journal of the American Medical Association has published a study that found women are 29% more likely than men to need revision surgery within 3 years of a total hip replacement procedure (arthroplasty). Researchers found that 2.3% of women and 1.9% of men needed surgery to replace a defective hip implant after an average of three years. Furthermore, metal-on-metal hip implants had double the risk of failure in women than in men, which is consistent with findings in several other recent studies.
In the past, studies suggested that the higher failure-rate in women might be due to a poor fit with larger-sized femoral heads. However, when the researchers controlled for this variable, they found that women were still 15% more likely than men to require revision surgery.
The data from the study is important because it comes from the largest registry of hip implants in the United States, involving more than 35,000 patients who had the procedure at 46 hospitals by 319 surgeons from 2001 through 2010. Various types of hip implants were used, including metal-on-metal hip implants and combinations of ceramic, metal, and polyethylene components.
There have been several high-profile recalls of hip implants in recent years, and the U.S. Food and Drug Administration (FDA) has published multiple warnings. The FDA has also published draft guidance for manufacturers to study the effectiveness of hip implants in women versus men. This guidance is voluntary, however, and most new hip implants are approved under the 510(k) approval process, which does not normally require new clinical trials.
Diana Zuckerman, president of the National Research Center for Women & Families, wrote an accompanying editorial to the paper. She argued that the 29% increased risk of revision surgery is of little use for women who need a hip implant, but instead indicates that more research needs to be conducted to improve designs and make good treatment choices for patients.
According to Zuckerman:
“What is urgently needed is long-term comparative effectiveness research based on large samples sizes, indicating which [hip implant] devices are less likely to fail in women and in men, with subgroup analysis based on age and other key patient traits, as well as key surgeon and hospital factors.”
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