Beyond joint implant registries: a patient-centered research consortium for comparative effectiveness in total joint replacement.

DESPITE THE PROVEN EFFECTIVENESS OF TOTAL joint replacement (TJR) surgery in relieving advanced knee and hip arthritis pain, TJR outcomes have come under intense public scrutiny in recent years. The 2010 recall of ASR metal-on-metal hip implants heightened awareness of the importance for implant safety surveillance for this high-cost and high-use procedure and exposed the need for a national systematic patient-centered outcomes monitoring system. These safety concerns and the exponential growth in TJR use— given the demographics of the baby boomer generation— emphasize the need for systematic comparative effectiveness research (CER) to inform patients, physicians, and policy makers about the optimal practices in TJR surgery. Recent estimates suggest that up to 500 000 US patients received a metal-on-metal hip implant between 2003 and 2010. Prior to the recall, case reports from across the globe documented unusually high rates of early postoperative revision surgery among patients with these implants. National registries of England and Wales, Australia, and New Zealand reported greater revision surgery rates with metal-on-metal implants compared with conventional metal-on-polyethylene implants. In hindsight, the first sign of implant failure was atypical patient-reported pain, followed by pathologic soft tissue changes. However, at the time, registries were not systematically documenting longitudinal patient-reported symptoms (eg, pain and physical function) after knee and hip surgery. The existence of such systematic patient-reported data may have brought attention to these implants earlier. There is a current need, in the United States in particular, for an efficient monitoring infrastructure of population-based, longitudinal, patientreported outcomes to provide evidence to inform patient and clinician decisions about optimal TJR timing, implant selection, surgical technique, and likely functional outcomes. To address this need, the Agency for Healthcare Research and Quality funded a 4-year $12 million research program, Function and Outcomes Research for Comparative Effectiveness in TJR (FORCE-TJR). Led by a team of researchers at the University of Massachusetts Medical School in cooperation with a national network of surgeons, FORCE-TJR assembled a consortium of orthopedic practices to serve as a research laboratory to generate CER to guide surgeon and patient decisions. The FORCE-TJR has a national scope, is representative of US practices, includes longitudinal patient-reported outcomes, and has the ability to measure implant failure as well as important clinical outcomes and complications.