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

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TRAUMA SURGERY

Can 3D‑printing avoid discomfort‑related implant removal in midshaft clavicle fractures? A four‑year follow‑up Rob F. M. van Doremalen1,2,4   · Rens A. van der Linde1,5 · Jan J. Kootstra1,6 · Sven H. van Helden1 · Edsko E. G. Hekman3 Received: 7 May 2020 / Accepted: 15 October 2020 © The Author(s) 2020

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 Keywords  Midshaft clavicle fracture · Plate fixation · Preoperative preparation · 3D-printing · Reoperation rate

* Rob F. M. van Doremalen [email protected] 1



Department of Surgery, Isala Hospital, 8000 GK Zwolle, The Netherlands

2



Department of Robotics and Mechatronics, Faculty of Electrical Engineering, Mathematics and Computer Science, University of Twente, P.O. Box 217, 7500 AE Enschede, The Netherlands

3

Department of Biomechanical Engineering, University of Twente, 7500 AE Enschede, The Netherlands

4

Deventer Hospital, 7400 GC Deventer, The Netherlands

5

Department of Surgery, Medisch Spectrum Twente, 7500 KA Enschede, The Netherlands

6

Department of Surgery, Hospital Group Twente, 7600 SZ Almelo, T