Mylène Jansen

136 Chapter 7 CD device versus 18/22 patients with the DD device). Baseline characteristics did not differ significantly between patients who did or did not fill out the questionnaire in each group. Results per question are provided in Table 4. Table 4 : Overview of user-friendliness questionnaire results per question for the concept distraction device and the dedicated distraction device # Aspect CD device DD device P- value Clothing and dressing (treated leg) 1 Changing clothes 7.0 (4.5) 8.5 (5.3) 0.281 2 Clothes catching on device 6.0 (3.8) 8.5 (4.3) 0.070 3 Finding suitable/fitting clothes 5.0 (4.5) 10.0 (3.0) 0.003 Sleeping and night rest 4 Sleeping in desired position 3.0 (3.0) 2.0 (4.0) 1.000 5 Disturbance of night rest 4.5 (2.0) 6.0 (8.0) 0.463 6 Damage to bedding 6.0 (6.0) 10.0 (0.0) 0.002 Pin care and device handling 7 Performing pin care 4.0 (4.0) 9.0 (6.0) <0.001 8 Understanding pin care instructions 8.0 (3.0) 10.0 (3.3) 0.274 9 Extending the device 8.0 (5.0) 10.0 (5.0) 0.791 10 Understanding extension instructions 9.0 (5.0) 9.0 (6.0) 1.000 Daily activities 11 Getting caught / bumping during daily activities 6.0 (5.0) 5.5 (3.3) 0.484 12 Getting in and out of chair 5.0 (7.0) 6.0 (9.0) 0.135 13 Performing daily activities 4.0 (2.0) 4.0 (4.0) 0.198 14 Harm to the other leg 7.5 (3.5) 10.0 (6.0) 0.003 15 Loosening/losing shielding caps from bone pins 7.0 (7.0) 8.5 (7.0) 0.735 Mobility 16 Walking without crutches 4.0 (3.0) 5.5 (6.3) 0.403 17 Resume daily domestic activities 3.0 (5.0) 4.0 (2.0) 0.042 18 Resume paid activities (job) 1.0 (0.0) 1.0 (4.0) 0.116 19 Daily traveled distance 3.0 (7.0) 4.0 (2.3) 0.175 Complications 20 Antibiotic courses started, n (n per patient) 29 (1.8)^ 29 (1.6)^ 0.463 21 Patients with pin tract infection, n (%) Total pin tract infections, n (n per patient) $ 14 (88)^ 77 (4.8)^ 10 (56)^ 66 (3.7)^ 0.041* 0.237 22 Doctor visits related to the device, n (%) 10 (63)^ 7 (39)^ 0.169* Other aspects 23 Need for new clothing 8.0 (3.0) 7.0 (2.8) 0.325 24 Importance of signs of previous use 1.0 (5.3)^ 4.5 (5.3)^ 0.102 25 Importance of device color 1.0 (0.0)^ 1.0 (2.0)^ 0.597 Median and interquartile range are given unless otherwise indicated. In all cases a higher value represents the best (most desirable) answer, except for values marked with ^. P- values were calculated using Mann-Whitney U Tests; for categorical parameters (indicated with *) chi-square tests were used instead. Statistically significant differences between devices ( p< 0.05) are indicated in bold. The original questionnaire is provided in the supplementary data file I. $: defined as the total number of pin tract infections over the course of the treatment for all patients with every infected pin tract counting separately; a pin tract be infected multiple times during a treatment period. CD: concept distraction; DD: dedicated distraction.

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