A randomized clinical trial comparing screws and the TighRope® Knotless system in the treatment of acute injuries of syndesmosis. / Ensayo clínico comparando el uso de tornillos y del sistema TighRope® Knotless en el tratamiento de las lesiones agudas de la sindesmosis.

BACKGROUND AND AIM: Classically acute syndesmosis injuries have been treated using screws. A few years ago more flexible implants appeared evolving to current TighRope® Knotless. The primary aim of this study is to compare clinical and radiographic outcome of both implants. MATERIAL AND METHODS: From April 2019 to September 2020 68 patients diagnosed with acute syndesmosis injury were randomized to use screws or TighRope® Knotless. Syndesmosis reduction was assessed using bilateral CT potsoperatively. Outcomes were clinically and radiologically assessed at three, six, and twelve months after surgery. RESULTS: No significant differences were identified in the AOFAS Scale between groups at three months (83.1 vs. 81.80; P=1.03), nor at six (88.27 vs. 88; P=.26) or at twelve (93.03 vs. 92.10; P=,93). There were also no differences in Olerud-Molander scale at three (65 vs. 61.50; P=3.5), six (82.33 vs. 80.67; P=1.67) and twelve months (92.67 vs. 90; P=2.67). Likewise, there were no differences in rate of postoperative malreduction (no cases in both groups), loss of reduction (three cases in screw group vs. four in TighRope® Knotless group, P=.54) or complications (P=1). CONCLUSIONS: Treatment of acute syndesmosis injuries with screws or the TighRope® Knotless implant is similar in both clinical and radiological results.