Regarding “FDA gets push for device registries”, hip and knee implant registries incorporating refined data for comparative effectiveness, quality monitoring and public reporting are clearly necessary. As implant designs and materials mature, and survival times lengthen, patient attributes and risk factors are emerging as key factors in predicting implant survivorship and functional outcomes. Information such as risk adjustment at the time of surgery—including patient-reported symptoms—to understand thresholds for revision would be most useful.
The Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) program has established a novel TJR registry with more than 21,000 patients enrolled from 136 surgeons in 22 states, with hundreds more patients enrolled weekly. FORCE-TJR is the first U.S. national cohort of TJR patients representing all regions of the U.S., with varied practice settings (e.g., urban and rural, high and low volume) to collect comprehensive TJR outcome data. Data are collected directly from patients—including patient-reported outcomes of pain and function, early post-operative adverse events and implant failures—assuring more than an 85% response for valid, longitudinal analyses.