Can 3D-printing avoid discomfort-related implant removal in midshaft clavicle fractures? A four-year follow-up

Abstract

Introduction: Due to the variation in shape and curvature of the clavicle, plates often have to be adjusted during surgery to acquire a good fit. Poorly fitted plates can cause discomfort, eventually requiring implant removal. 3D-printed replicas of the fractured clavicle can assist in planning of the surgical approach, plate selection and, if necessary, adjustment of the plate prior to surgery. We hypothesized this method of preoperative preparation would reduce implant-related discomfort resulting in a reduced reoperation rate Materials and methods: In a prospective cohort study, perioperative plate handling and clavicle fixation were timed and follow-up data were collected from participants undergoing operative treatment for a midshaft clavicle fracture. The control group (n = 7) received conventional surgery with standard precontoured plates. For the intervention group (n = 7), 3D-printed replicas of the fractured clavicle and a mirrored version of the healthy contralateral clavicle were available prior to surgery for planning of the surgical approach, and for plate selection and contouring. Primary outcome was reoperation rate due to implant-related discomfort. Secondary outcomes were complications and time differences in the different surgical phases (reduction, fixation and overall operation time) Results: More participants in the control group had the plate removed due to discomfort compared to the intervention group (5/7 vs. 0/6; P = 0.012). One participant was excluded from the intervention group due to a postoperative complication; an infection occurred at the implant site. No relevant time difference in surgical plate handling was found between both groups. Conclusions: Preoperative preparation using 3D-printed replicas of the clavicle fracture may reduce implant removal caused by plated-related discomfort. No relevant effect on surgery time was found. Trial registration: Registered with ‘toetsingonline.nl’, trial number NL51269.075/14, 17-02-2015