Guidance on Combination Knee Products Stresses Primary Endpoints

Primary endpoints for Phase III clinical trials of combination products used to repair knee cartilage should be either improvement in physical function or reduction of pain, according to an FDA final guidance. These should be assessed on recognized measures, such as the Knee Injury and Osteoarthritis Outcome Score; the IKDC Subjective Knee Evaluation Form; the Cincinnati Knee Rating System; the Symptom Rating Form; and the Western Ontario and McMaster Universities Osteoarthritis Index, the guidance states.
Devices & Diagnostics Letter