Phase III Knee Osteoarthritis DMOAD Trial

Challenge

Demonstrating disease modification in knee osteoarthritis hinges on detecting submillimeter changes in joint space narrowing over extended follow-up. The sponsor required readings of sufficient precision to register these minute structural changes, together with consistent tracking of WORMS scores across 24 months of serial MRI examinations. Because the primary structural endpoint rested on longitudinal comparison, any drift in reader interpretation or measurement technique over the study's duration would directly compromise the trial's conclusions.

Our Solution

Intrinsic Imaging assigned fellowship-trained musculoskeletal radiologists to conduct paired longitudinal reviews of high-resolution knee MRI and radiographs, with readers blinded to the chronological order of timepoints to eliminate expectation bias. Calibrated measurement tools and a detailed reading charter governed every assessment, while periodic re-qualification exercises confirmed that reader performance remained stable across the full two-year follow-up period.

Results

• Reader intraclass correlation above 0.94
• Central imaging assessments supported the primary structural endpoint
• Consistent longitudinal scoring across readers