Mylène Jansen

116 Chapter 6 Table 1 : Baseline characteristics of patients treated with knee joint distraction in regular care and in clinical trials Regular care (n=84) Clinical trial (n=62) P- value Age (years) 53.1 (6.9) 51.5 (6.9) 0.173 Male sex, n (%) 52 (62) 36 (58) 0.639* BMI (kg/m 2 ) 27.9 (3.7) 28.2 (3.7) 0.639 Left index knee, n (%) 43 (51) 26 (42) 0.268* Range of motion (degrees) 124.2 (17.8) 122.7 (14.7) 0.602 Leg axis (degrees) 4.3 (5.1) 4.9 (4.4) 0.556 Varus/valgus, n (%) 57 (68) / 16 (19) 28 (45) / 3 (5) 0.140* Kellgren-Lawrence grade, n (%) - Grade 0 - Grade 1 or 2 - Grade 3 or 4 0 (0) 19 (23) 64 (76) 0 (0) 18 (29) 44 (71) 0.401* Distraction duration (days) 45.3 (4.3) 48.1 (8.1) 0.019 Mean and standard deviation or n (%) are given. P- values are calculated with independent t -tests and for categorical variables with chi-square tests (indicated with *). Bold p- values indicate statistical significance ( p< 0.05). BMI: body mass index. Cartilaginous tissue repair Radiographs of a representative regular care patient and a trial patient pre-treatment and 1 year post-treatment are shown in Figure 2. Figure 2 : Representative radiographs pre-treatment and 1 year post-treatment for regular care and clinical trial patient. Note the aluminum step wedge needed for joint space width quantification as used in clinical trials.