Mylène Jansen

138 Chapter 7 was better or slightly better than the CD than the other way around, but no statistical testing was performed because of the small size of this group (n=3). Figure 4 : Questionnaire results from patients that received treatment with both devices. Statistical testing was not opportune for this small number of responders (n=3). CD: concept distraction; DD: dedicated distraction. Discussion The performance of a DD device for KJD, in terms of user-friendliness, was evaluated against a CD device in clinical practice amongst the primary intended users, viz. surgeons and patients. The development of the DD device focused on optimization of use-related aspects that had no direct effect on the safety of the device, with essential characteristics kept equal to the CD device. As such, the DD device was introduced according to the applicable regulations without a study on clinical efficacy. It was found that the DD device for KJD provides improved user- friendliness for both clinicians (reduced surgery time) and patients as compared to the CD device. Independently of the user-friendliness of the device, it remains to be evaluated whether the DD device has similar clinical efficacy as the CD device.