Invited Commentary by Diana Zuckerman, PhD in JAMA Internal Medicine, published online February 18, 2013
Total hip replacement is a popular procedure that is increasing as baby boomers age. A new study by Inacio et al in this issue of JAMA Internal Medicine reports that most hip implant patients are women, and that their risk of implant failure is higher than men’s.
Sex-specific analyses are rare in medical devices but are especially important in orthopedics because of substantial anatomical sex differences. These data of Inacio et al are an important first step in understanding higher hip implant revision rates in women. However, longer follow-up is necessary for hip implants, and the relatively small number of revisions and large number of potentially confounding variables in these short-term data make it challenging to use these data to help reduce the likelihood of revision surgery. It is not helpful to women patients to know that the risks are higher than they are for men. What is urgently needed is long-term comparative effectiveness research based on larger sample sizes, indicating which implants are less likely to fail in women and in men, with subgroup analyses based on age and other key patient traits, as well as key surgeon and hospital factors. Such data would enable patients and their physicians to choose the hip devices and surgical techniques that are most likely to be successful for a longer period.
Unfortunately, the FDA does not require hip implant manufacturers to conduct clinical trials in humans prior to selling most hip implant devices. Such studies would allow better informed choices for the more than 300,000 U.S. patients undergoing this surgery every year, and would reduce the need for revision surgery and lower the number of heart attacks and other risks associated with the surgery.
(JAMA Intern Med. Published online February 18, 2013. doi:10.1001/jamainternmed.
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.