About the Late-stage Knee and Hip Osteoarthritis Composite Measure Working Group
The receipt of a total knee (TKR) or hip replacement (THR) has commonly been used in clinical trials as an outcome measure of “late-stage” osteoarthritis (OA). However, total joint replacement outcomes are highly variable, dependent on a patient’s access and preference for surgery, the surgeon’s preference, socio-economic and geographical factors. There have been calls by the clinical trial community and clinical regulators to define a clinical endpoint for “late stage OA”, leading to the development of a new composite measure that can be used as both an outcome measure or inclusion/exclusion criteria in clinical trials.
The aims of this working group are to generate and define a set of candidate target domains to be included in all studies that aim to prevent or reduce TKR or THR, with a view to future developing a composite measure of the late-stage OA.
Working Group Members:
Celeste Scotti, Global Program Clinical Head
Jürgen Löffler, Director Biostatistics