Randomized Trial Comparing Suture Button with Single Syndesmotic Screw for Syndesmosis Injury.

Background: This study compared clinical and radiographic results between patients who underwent stabilization of an acutely injured syndesmosis with a suture button (SB) and those treated with 1 quadricortical syndesmotic screw (SS).

Methods: Ninety-seven patients, 18 to 70 years old, with an ankle injury that included the syndesmosis were randomized to 2 groups: SB (48 patients) and SS (49). The main outcome measure was the score on the American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot scale. The secondary outcome measures were the Olerud-Molander Ankle (OMA) score, visual analog scale (VAS), and EuroQol-5D (EQ-5D) Index and VAS. Computed tomography (CT) scans of both ankles were obtained at 2 weeks and 1 and 2 years after surgery. Both groups were allowed partial weight-bearing at 2 weeks and full weight-bearing at 6 weeks. The mean time for SS removal was 85.9 days (range, 39 to 132 days) after surgery. The patients were followed at 6 weeks, 6 months, and 1 and 2 years. Two years of follow-up were completed for 87 (90%) of the patients (46 in the SB group and 41 in the SS group).

Results: The SS group had more injuries to the posterior malleolus than the SB group. At 2 years, the median AOFAS score was higher in the SB group than in the SS group (96 [interquartile range, or IQR, 90 to 100] versus 86 [IQR, 80 to 96]; p = 0.001), as was the median OMA score (100 [IQR, 95 to 100] versus 90 [IQR, 75 to 100]; p < 0.001). The SB group reported less pain during walking at 2 years than the SS group (median VAS score, 0 [IQR, 0 to 1] versus 1 [IQR, 0 to 2]; p = 0.008) and less pain during rest (median VAS score, 0 [IQR, 0 to 0] versus 0 [IQR, 0 to 1]; p = 0.04). There was no difference between treatments groups with regard to pain at night or during daily activities at 2 years. The SB group had a higher median EQ-5D Index score at 2 years (1.0 [IQR, 1 to 1] versus 0.88 [IQR, 0.8 to 1.0]; p = 0.005). Twenty of 40 patients in the SS group had a difference in the tibiofibular distance of ≥2 mm between the injured and uninjured ankles at 2 years, compared with 8 of 40 in the SB group (p = 0.009). Seven patients in the SS group had symptomatic recurrent syndesmotic diastasis during the treatment period compared with none in the SB group (p = 0.005).

Conclusions: The patients treated with an SB had higher AOFAS scores, OMA scores, and EQ-5D Index scores as well as lower (better) VAS scores for pain during walking and pain during rest. Also, the SB group had less widening seen radiographically at 2 years than did the patients in the SS group. No differences in the scores for pain at night or during daily activities were identified.

Level Of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.