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

Abstract

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.

The minimal clinically important difference (MCID) of the Olerud Molander Ankle Score (OMAS) in patients with unstable ankle fracture

“…Gausden et al showed that there is a larger difference in MCID at different time points with a larger MCID at the 3 versus 6 months interval compared to the 6 versus 12 months interval (MCID of 17.6 versus 3.8, respectively) [23]. Our results also show a larger MCID at 3 versus 6 months, compared to 6 versus 12 months interval, which could be explained by the fact that the functional improvement following surgery is larger between 3 and 6 months than between 6 and 12 months [15,24,25].…”

“…This study was a prospective cohort study, conducted alongside a randomized controlled trial. To define the MCID of the OMAS, we extracted data from the RODEO trial, an international randomized controlled trial on removal of syndesmotic screws after ankle surgery, which included patients between January 2017 and April 2019 [15]. Patients were randomized to either routine removal of the syndesmotic screw or removal on demand.…”

“Flexible nature of fixation” in syndesmotic stabilization of the inferior tibiofibular joint affects the radiological reduction outcome

“…However, the extent to which the use of a second parallel or divergent SBS affects the FNF is still lacking. In view of this and the costs, which are lower in total than the use of a SYS and sequential material removal after 6 to 8 weeks, stabilization with one SBS is performed in our own center [ 22 ], whereby the routine removal of the SYS should be critically discussed [ 47 ]. Possible position-dependent measurement inaccuracies could be reduced by standardized positioning of the feet and exact adjustment of the CT planes but cannot be completely eliminated.…”

Foot & Ankle

“…A cohort of patients who underwent ACL reconstruction over a ten-year period between 2002 and 2012, who had at least eight years' followup, were retrospectively reviewed by this study team, based in Bergen (Norway). 4 Preoperative sagittal radiographs of the knee in full extension were used to measure the PTS (assessed by two independent examiners).…”

“…Investigators from Amsterdam (The Netherlands) conducted a pragmatic randomized trial to compare ODR and RR on a noninferiority basis. 4 All adults with traumatic syndesmotic injury treated surgically within two weeks of injury were eligible. For the purposes of the study, the exclusion criteria were an Injury Severity Score > 15, a physical comorbidity that may affect potential screw removal, concomitant injury of the ipsi-or contralateral side or other medical conditions hampering rehabilitation, and insufficient comprehension of English, Dutch, Finnish, or the Swedish language.…”