Decision-making considerations in application of biodegradable fixation systems in maxillofacial surgery--a retrospective cohort study.

In a recent RCT comparing biodegradable (Inion CPS) with titanium (KLS Martin) plates and screws for fixation of osteotomies or fractures, we found that in 21% of the cases the surgeon decided intra-operatively to switch from biodegradable to titanium. The aim of the current retrospective cohort study was to analyse the reasons for these switches in order to find predictor variables that may be helpful in the decision to use biodegradable devices or not. The surgeons' opinion about the biodegradable system, and if there was a learning curve in the application of the biodegradable system were also investigated. All variables were assessed during the original RCT by using a questionnaire that was completed by the OMF surgeon directly post-operatively. For the outcome variable "surgeons' opinion" a separate questionnaire was used. Regarding the predictor variables a mandibular fracture had a higher risk of switching compared to a BSSO. However, looking at the reasons for these switches no firm conclusions can be drawn. There was a subjective learning curve to acquire the application-skills for the biodegradable system. There were no changes in isolated Le-Fort-I osteotomies despite the fact that the biodegradable system seems more difficult to apply in the midface. Inadequate stability was the main reason for switching. This can be material-related, or related to inexperience with or lack of confidence in the system, or impatience of the surgeon. A learning curve and personal preferences probably play an important role in the decision to switch. We think that with more patience and more experience it should be possible to increase both user comfort and confidence in the biodegradable system of Inion CPS, which likely will decrease the number of intra-operative switches.

RCT Entities:   Population Interventions Outcomes