Randomized trial comparing suture button with single 3.5 mm syndesmotic screw for ankle syndesmosis injury: similar results at 2 years

Benedikte Wendt Ræder, Ingrid Kvello Stake, Jan Erik Madsen, Frede Frihagen, Silje Berild Jacobsen, Mette Renate Andersen, Wender Figved, Benedikte Wendt Ræder, Ingrid Kvello Stake, Jan Erik Madsen, Frede Frihagen, Silje Berild Jacobsen, Mette Renate Andersen, Wender Figved

Abstract

Background and purpose - Better outcomes are reported for suture button (SB) compared with syndesmotic screws (SS) in patients treated for an acute ankle syndesmotic injury. One reason could be that screws are more rigid than an SB. A single tricortical 3.5 mm syndesmotic screw (TS) is the most dynamic screw option. Our hypothesis is that 1 SB and 1 TS provide similar results. Therefore, in randomized controlled trial, we compared the results between SB and TS for syndesmotic stabilization in patients with acute syndesmosis injury. Patients and methods - 113 patients with acute syndesmotic injury were randomized to SB (n = 55) or TS (n = 58). The American Orthopedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot Score was the primary outcome measure. Secondary outcome measures included Manchester Oxford Foot Questionnaire (MOXFQ), Olerud-Molander Ankle score (OMA), visual analogue scale (VAS), EuroQol- 5D (EQ-5D), radiologic results, range of motion, complications, and reoperations (no implants were routinely removed). CT scans of both ankles were obtained after surgery, and after 1 and 2 years. Results - The 2-year follow-up rate was 84%. At 2 years, median AOFAS score was 97 in both groups (IQR SB 87-100, IQR TS 90-100, p = 0.7), median MOXFQ index was 5 in the SB group and 3 in the TS group (IQR 0-18 vs. 0-8, p = 0.2), and median OMA score was 90 in the SB group and 100 in the TS group (IQR 75-100 vs. 83-100, p = 0.2). The syndesmotic reduction was similar 2 years after surgery; 19/55 patients in the SB group and 13/58 in the TS group had a difference in anterior syndesmotic width ≥ 2 mm (p = 0.3). 0 patients in the SB group and 5 patients in the TS group had complete tibiofibular synostosis (p = 0.03). At 2 years, 10 TS were broken. Complications and reoperations were similar between the groups. Interpretation - We found no clinically relevant differences regarding outcome scores between the groups. TS is an inexpensive alternative to SB.

Trial registration: ClinicalTrials.gov NCT02930486.

Figures

Figure 1.
Figure 1.
CONSORT flowchart of the trial enrollment and analysis.
Figure 2.
Figure 2.
CT of injured ankle (upper panel) and uninjured ankle (lower panel) in a 20-year-old woman, 2 years after injury. Tibiofibular distance is measured on axial CT 1 cm proximal to the ankle joint. Distance measured anterior (A); central (C); and posterior (P).
Figure 3.
Figure 3.
AOFAS equivalence diagram. Blue area indicates margins of equivalence defined as the between-group difference of 10 points. Results at all time intervals are equivalent since the 95% CI lies wholly inside the margins.

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Source: PubMed

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