A Prospective Randomized Investigation Comparing Functional Outcomes of Syndesmotic Suture-Button Fixation to Screws

Abstract

AIM: To compare functional outcomes and adverse events of surgically treated syndesmotic injuries with either screws(s) or a suture-button device(s). It was hypothesized that suture-button fixation would provide equal clinical results with fewer adverse events.

MATERIALS AND METHODS: Multi-center, randomized clinical study. Sixty-five subjects with confirmed acute syndesmotic injury requiring surgical intervention were enrolled. Subjects were randomized and treated with either suture-button or screw fixation.  Foot and Function Index pain, disability, and activity scores, American Orthopaedic Foot and Ankle Society, and the Visual Analogue Scale for pain were reported up until 12-months. The adverse events were also collected. The forty subjects with complete data up to one year (n=40; suture-button =18 and screw=22) were included in analysis. Single or multiple screws or suture-button implants were based on surgeon preference and patients’ characteristics.

RESULTS: There was statistically significant improvement in Foot and Function Index and American Orthopaedic Foot and Ankle Society scores with both techniques (p < 0.05). With the exception of Visual Analogue Scale scores with suture-button, the Visual Analogue Scale scores also improved significantly (p<0.05). When the techniques were compared, there were no differences in scores, with the exception of significantly lower pain scores with suture-button device (p > 0.05).  Syndesmotic screws had higher adverse events compared to suture-button (32 % versus 6%), which approached statistical significance (p = 0.054).

CONCLUSION: One-year clinical data suggests that acute syndesmotic injuries can be effectively treated with either technique. An important benefit of suture-button fixation is a lower occurrence of adverse clinical events.