Functional outcome of routine versus on-demand removal of the syndesmotic screw: a multicentre randomized controlled trial

Aims The aim of this study was to investigate whether on-demand removal (ODR) is noninferior to routine removal (RR) of syndesmotic screws regarding functional outcome. Methods Adult patients (aged above 17 years) with traumatic syndesmotic injury, surgically treated within 14 days of trauma using one or two syndesmotic screws, were eligible (n = 490) for inclusion in this randomized controlled noninferiority trial. A total of 197 patients were randomized for either ODR (retaining the syndesmotic screw unless there were complaints warranting removal) or RR (screw removed at eight to 12 weeks after syndesmotic fixation), of whom 152 completed the study. The primary outcome was functional outcome at 12 months after screw placement, measured by the Olerud-Molander Ankle Score (OMAS). Results There were 152 patients included in final analysis (RR = 73; ODR = 79). Of these, 59.2% were male (n = 90), and the mean age was 46.9 years (SD 14.6). Median OMAS at 12 months after syndesmotic fixation was 85 (interquartile range (IQR) 60 to 95) for RR and 80 (IQR 65 to 100) for ODR. The noninferiority test indicated that the observed effect size was significantly within the equivalent bounds of -10 and 10 scale points (p < 0.001) for both the intention-to-treat and per-protocol, meaning that ODR was not inferior to RR. There were significantly more complications in the RR group (12/73) than in the ODR group (1/79) (p = 0.007). Conclusion ODR of the syndesmotic screw is not inferior to routine removal when it comes to functional outcome. Combined with the high complication rate of screw removal, this offers a strong argument to adopt on demand removal as standard practice of care after syndesmotic screw fixation. Cite this article: Bone Joint J 2021;103-B(11):1709–1716.

Does the orientation of syndesmosis fixative device affect the immediate reduction of the distal tibiofibular joint?

Introduction Incongruent stabilization of the distal tibiofibular joint (syndesmosis) results in poorer long-term outcome in malleolar fractures. The aim was to analyze whether the orientation of the syndesmotic stabilization would affect the immediate reduction imaged in computed tomography (CT). Materials and methods The syndesmotic congruity in 114 ankle fractures with stabilization of the syndesmosis were retrospectively analyzed in the post-operative bilateral CT scans. The incisura device angle (IDA) was defined and correlated with the side-to-side difference of Leporjärvi clear-space (ΔLCS), anterior tibiofibular distance (ΔantTFD) and Nault talar dome angle (ΔNTDA) regardless of the stabilization technique and separately for suture button system and syndesmotic screw. Asymmetric reduction was defined as ΔLCS > 2 mm and |ΔantTFD|> 2 mm. Results Regardless of the stabilization technique, no correlation between the IDA and the ΔLCS (r = 0.069), the ΔantTFD (r = 0.019) nor the ΔNTDA (r = 0.177) could be observed. There were no differences between suture button system and syndesmotic screw. Asymmetrical reduction was detected in 46% of the cases, while sagittal asymmetry was most common. No association was found between the orientation of stabilization device and occurrence of asymmetrical reduction (p > 0.05). The results of suture button system and syndesmotic screw were comparable in this respect (p > 0.05). Conclusion Poor correlation between the orientation of the stabilization device and the immediate post-operative congruity of the syndesmosis could be shown. In contrast to current literature, this study did not show difference of suture button system over syndesmotic screw in this regard. Careful adjustment of the fibula in anteroposterior orientation should be given special attention.