Effectiveness, safety, and cost-utility of a knee brace in medial knee osteoarthritis: the ERGONOMIE randomized controlled trial.

OBJECTIVE: This pragmatic, multicenter, open-label, randomized controlled trial (RCT) aimed to compare the effectiveness, safety, and cost-utility of a custom-made knee brace versus usual care over 1 year in medial knee osteoarthritis (OA). DESIGN: 120 patients with medial knee OA (VAS pain at rest >40/100), classified as Kellgren-Lawrence grade II-IV, were randomized into two groups: ODRA plus usual care (ODRA group) and usual care alone (UCA group). The primary effectiveness outcome was the change in VAS pain between M0 and M12. Secondary outcomes included changes over 1 year in KOOS (function) and OAKHQOL (quality of life) scores. Drug consumption, compliance, safety of the knee brace, and cost-utility over 1 year were also assessed. RESULTS: The ODRA group was associated with a higher improvement in: VAS pain (adjusted mean difference of -11.8; 95% CI: -21.1 to -2.5); all KOOS subscales (pain: +8.8; 95% CI: 1.4-16.2); other symptoms (+10.4; 95% CI: 2.7-18); function in activities of daily living (+9.2; 95% CI: 1.1-17.2); function in sports and leisure (+12.3; 95% CI: 4.3-20.3); quality of life (+9.9; 95% CI: 0.9-15.9), OAKHQOL subscales (pain: +14.8; 95% CI: 5.0-24.6); and physical activities (+8.2; 95% CI: 0.6-15.8), and with a significant decrease in analgesics consumption at M12 compared with the UCA group. Despite localized side-effects, observance was good at M12 (median: 5.3 h/day). The ODRA group had a more than 85% chance of being cost-effective for a willingness-to-pay threshold of €45 000 per QALY. CONCLUSIONS: The ERGONOMIE RCT demonstrated significant clinical benefits of an unloader custom-made knee brace in terms of improvements in pain, function, and some aspects of quality of life over 1 year in medial knee OA, as well as its potential cost-utility from a societal perspective.

Test-retest reliability and responsiveness of centre of pressure measurements in patients with hip osteoarthritis.

OBJECTIVE: The aim of this study was to determine a set of measures for the evaluation of balance in patients suffering from hip osteoarthritis (OA) that were both reliable and responsive to change. DESIGN: Three groups of subjects; Healthy, hip OA patients without surgery, and hip OA with surgery (pre and post-surgery) were included in this study. Subjects had to perform balance tests in two positions: standard and narrowed stance. CoP-based measures test-retest reliability was assessed in hip OA without surgery group, responsiveness were assessed between all groups and between pre and post-surgery. RESULTS: Intraclass Correlation Coefficient (ICC) values from hip OA without surgery ranged from -0.03 to 0.9 for only five parameters (CoP path length, SD velocity, mean velocity, and antero-posterior Root Mean Square (RMS(AP)) having values over 0.7. SD velocity and RMS(AP) showed significant differences between healthy and surgery group in standard stance whereas narrowed stance revealed most differences between all groups. RMS(AP) showed the best responsiveness (Standardized Response Mean ∼0.5) between pre vs post-surgery in both conditions. RMS(AP) was also capable of discriminating between hip OA with surgery vs without surgery groups with good sensitivity and specificity. CONCLUSIONS: Our results showed there to be reliability and responsiveness of five postural parameters in hip OA patients in two conditions of standing balance. More parameters were significantly different in narrowed stance whereas sensitivity was better in standard stance. SD velocity and RMS(AP) discriminate between degrees of OA severity and highlight potential balance deficits even after arthroplasty. Selected parameters during standing balance could be assessed to complete the set of quantitative measures to quantify hip OA patient deficiencies.