Purpose: Suture button devices for tibiofibular syndesmosis injuries provide semirigid dynamic stabilization, but complications including knot irritation have been reported. No randomized trials of the new knotless suture button devices have been performed. We hypothesized that knotless suture button devices eliminate knot irritation and facilitate quicker return to sports. This study was performed to compare the clinical outcomes, complication rates, and time to return to sports between a new knotless suture button device and syndesmotic screw fixation.
Methods: This study included 54 patients treated for ankle syndesmotic injury from 2012 to 2014 with a knotless suture button device or syndesmotic screw fixation. Clinical outcomes were measured using the American Orthopaedics Foot and Ankle Society score, Foot and Ankle Disability Index, Olerud and Molander score, and visual analog scale for pain and function. Secondary outcome measures were the complication rate and time required to return to sports. Patients underwent clinical and radiological evaluations preoperatively and three times during the 1-year postoperative follow-up.
Results: 54 of 62 eligible patients were analyzed, median age 37 (18-60) and underwent the 1-year follow-up. The screw fixation and knotless suture button groups comprised 26 and 28 patients, respectively. The complication rate was significantly lower (p = 0.03) and time to return to sports was significantly shorter in the knotless suture button than screw fixation group (average, 14 versus 19 weeks, respectively; p = 0.006). No significant differences were identified in clinical outcomes or visual analog scale scores for pain and function between the groups. Age, injury mechanism, and body mass index did not significantly affect the time required to return to sports activities. The type of fixation was the only independent variable that reached statistical significance (p = 0.006).
Conclusion: Syndesmotic screw fixation and the new knotless suture button device both resulted in good clinical results. Lower complication rate and the earlier time to return to sports make the new knotless suture button device recommendable especially for highly active patients.
Level of evidence: Randomized controlled trial, Level I.
Keywords: Ankle syndesmosis; Complication rate; Functional outcome; Knotless suture button device; Syndesmotic screw; Time to return to sports.