Abstract
Purpose: Historically, clinical trials of knee osteoarthritis (OA) have relied on radiographic joint-space width as the primary structural endpoint. Recently, the FDA has indicated that imaging biomarkers of relevance to clinically important outcomes may be considered with sufficiently supportive data, including MRI-based cartilage evaluations. Knee replacement (KR) is considered a clinically relevant endpoint for knee OA since it is typically performed for severe symptomatic knee OA that has failed other therapies and thus considered ‘end-stage’.
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