Mylène Jansen

174 Chapter 9 Table 1 : Baseline parameters of both patient groups KneeReviver (n=39) Dynamic Monotubes (n=39) P- value BMI (kg/m 2 ) 27.6 (3.0) 27.2 (3.5) 0.532 Age (years) 52.4 (7.0) 53.7 (6.6) 0.407 Male sex, n (%) 22 (56) 23 (59) 0.819* WOMAC pain (0–100) 41.0 (16.0) 52.0 (16.0) 0.003 WOMAC stiffness (0–100) 32.7 (18.2) 47.3 (18.4) 0.001 WOMAC function (0–100) 42.2 (15.1) 55.1 (16.0) <0.001 WOMAC total (0–100) 41.2 (14.9) 53.8 (15.6) <0.001 VAS pain (10–0) 6.9 (1.2) 6.0 (2.2) 0.024 SF-36 PCS (0–100) 31.5 (6.8) 35.9 (8.2) 0.012 SF-36 MCS (0–100) 53.6 (9.3) 54.7 (8.2) 0.573 JSW minimum (mm)* 1.0 (1.2) 0.5 (0.9) 0.091 JSW (mm) MAC* 2.7 (1.8) 2.2 (1.8) 0.169 JSW (mm) LAC* 7.4 (2.0) 8.4 (2.0) 0.038 JSW (mm) mean* 5.0 (1.2) 5.2 (1.2) 0.497 Mean and standard deviation or n (%) are given of all 39 patients (* 38 patients) with full data and images sets (for the KneeReviver patients, these were the first 39 patients with complete data sets). P- values were calculated with independent t -tests, or chi-square tests for categorical variables (indicated with *). Bold p- values indicate statistical significance ( p< 0.05). BMI: body mass index; JSW: joint space width; LAC: least affected compartment; MAC: most affected compartment; MCS: mental component scale; PCS: physical component scale; SF-36: short-form 36; VAS: Visual Analogue Scale; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index. Complications The complications that occurred in the 39 KneeReviver patients are summarized in Table 2. The number of complications and the number of pin tract infections in these 39 patients were not statistically significantly different from the whole group of 65 KneeReviver patients (both p> 0.4). Because of differences in registration of complications, no direct comparison between patients treated with the Dynamic Monotubes and patients treated with the KneeReviver can be made. Complications occurring during and after treatment with the Dynamic Monotubes have been previously described. 8–10,22 One-year outcomes In the KneeReviver treated patients, the total WOMAC and minimum JSW both showed a statistically significant 1-year increase (both p< 0.014), as shown in Table 3 and Figure 2 for these primary outcomes. Also, all WOMAC subscales, the VAS pain, and SF-36 PCS improved significantly upon treatment with the KneeReviver (all p< 0.001), while the SF-36 MCS as expected showed no significant 1-year change ( p= 0.778). The other JSW parameters increased statistically significantly after treatment with the KneeReviver as well (all p< 0.05). There were no statistically significant differences in 1-year changes between centers of the KneeReviver trial (all p> 0.06).