Mylène Jansen

KJD in regular care 119 6 Table 3, showing a significant difference only in distraction duration, which again was longer for clinical trial patients (48.2 (SD 8.2) days; regular care 45.5 (4.2); p= 0.032), but shorter when excluding the OPS patients (RCT 42.8 (2.3); regular care 45.5 (4.2); p= 0.001). No statistical significant differences between the 43 regular care patients without and 41 patients with 1 year follow-up data were observed. Table 3 : Baseline characteristics of patients treated with knee joint distraction in regular care and in clinical trials, who completed both WOMAC baseline and 12-month follow-up questionnaires Regular care (n=41) Clinical trial (n=61) P- value Age (years) 54.0 (6.9) 51.7 (6.8) 0.102 Male sex, n (%) 23 (56) 35 (57) 0.898* BMI (kg/m 2 ) 27.5 (3.9) 28.1 (3.7) 0.508* Left index knee, n (%) 19 (46) 26 (43) 0.711 Range of motion (degrees) 125.4 (14.1) 122.7 (14.9) 0.362 Leg axis (degrees) 4.6 (4.7) 4.8 (4.4) 0.879 Varus/valgus, n (%) 33 (80) / 6 (15) 27 (44) / 3 (5) 0.510* Kellgren-Lawrence grade, n (%) - Grade 0 - Grade 1 or 2 - Grade 3 or 4 0 (0) 7 (17) 34 (83) 0 (0) 18 (30) 43 (70) 0.152* Distraction duration (days) 45.5 (4.2) 48.2 (8.2) 0.032 WOMAC Total (0–100) 47.5 (14.9) 49.8 (15.7) 0.464 WOMAC Pain (0–100) 46.3 (16.9) 49.8 (15.7) 0.293 WOMAC Stiffness (0–100) 39.3 (23.1) 45.4 (18.3) 0.141 WOMAC Function (0–100) 48.9 (15.2) 51.0 (16.2) 0.498 Mean and standard deviation or n (%) are given. P- values of continuous variables are calculated with independent t -tests and for categorical variables with chi-square tests (indicated with *). Bold p- values indicate statistical significance. BMI: body mass index; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index. As shown in Table 4 and Figure 4, the total WOMAC (Figure 4A) and pain (Figure 4B), stiffness (Figure 4C), and function (Figure 4D) subscales increased statistically and clinically significantly for the 41 regular care patients and 61 clinical trial patients that completed the questionnaires (all p< 0.001). Although there was a tendency towards better results for the clinical trial patients, no clinically or statistically significant differences in 1-year changes between regular care and trial patients were observed (all p> 0.068). Similar data were found for OPS and RCT patients separately, although for OPS patients slightly, but not statistically significantly, better results were obtained. After 1 year, 70% of patients were OMERACT-OARSI responders (regular care 61%, clinical trial 75%; p= 0.120).