Cross-sectional reliability and concurrent validity of a quantitative 2-dimensional ultrasound image analysis of effusion and synovial hypertrophy in knee osteoarthritis

Objective: Effusion-synovitis is related to pain and progression in knee osteoarthritis (OA), but current gold standard ultrasound (US) measures are limited to semi-quantitative grading of joint distension or 1-dimensional thickness measures. A novel quantitative 2-dimensional image analysis methodology is applied to US images of effusion-synovitis; reliability and concurrent validity was assessed in patients with knee OA. Methods: Cross sectional analysis of US images collected from 51 patients with symptomatic knee OA were processed in ImageJ and segmented in 3DSlicer to produce a binary mask of the supra-patellar synovitis region of interest (ROI). Area measures (mm²) of total synovitis, effusion and hypertrophy components were exported. Intra-rater reliability and test-retest reliability (1-14 days washout) were estimated with intra-class correlation coefficients (ICCs). Concurrent validity was measured by Spearman correlations between quantitative measures and gold standard OMERACT and caliper measurements of synovitis. Results: Intra-rater reliability for hypertrophy area was estimated at 0.98, 0.99 for effusion area, and 0.99 for total synovitis area. The test-retest reliability for total synovitis area was 0.63 (SEM 87.8 ​mm²), 0.59 for hypertrophy area (SEM 21.0 ​mm²), and 0.64 for effusion area (SEM 73.8 ​mm²). Correlation between total synovitis area and OMERACT grade was 0.84, 0.81 between total synovitis area and effusion-synovitis calipers, and 0.81 between total effusion area and effusion calipers. Conclusion: This new research tool for image analysis demonstrated excellent intra-rater reliability, good concurrent validity, and moderate test-retest reliability. Quantitative 2D US measures of effusion-synovitis and its individual components may enhance the study and management of knee OA.