Clinical and Radiographic Results Following Treatment of Traumatic Syndesmotic Instability Utilizing a Novel Screw-Suture Syndesmotic Fixation Device

The objective of this study was to report early outcomes of a novel screw-suture syndesmotic device compared to suture button fixation devices when treating traumatic syndesmotic instability. Methods: Design: Retrospective chart review. Single academic Level-1 Trauma Center All adult patients who had syndesmotic fixation with the novel device (NSRI group) compared to a suture button device (SB group) between January 2018 and December 2022. Outcome Measures and Comparisons: Medial clear space (MCS) and tibiofibular overlap (TFO) measurements were compared immediately post-operatively and at final follow-up. Patients were followed for a minimum of 1-year or skeletal healing. Fifty-nine patients (25 female) with an average age of 47 years (range 19-78 years) were in the NSRI group compared to 52 patients (20 female) with an average age of 41 years (range 18-73 years) in the SB group. There were no significant differences when comparing Body Mass Index, diabetes, or smoking status between groups (p>0.05). There was no difference when comparing the post-operative and final MCS measurements in the NSRI group compared to the SB group (p=0.86; 95% CI [-0.32, 0.27). There was no difference when comparing the post-operative and final TFO measurements in the NSRI group compared to the SB group (p=0.79; 95% CI [-0.072, 0.09). There were 3 cases of implant removal in the NSRI group compared to 2 in the SB group (p=0.77). There was one failure in the NSRI group and none in the SB group. The remaining patients were all fully ambulatory at final follow-up (p=0.35). A novel screw-suture syndesmotic implant provides the fixation of a screw and the flexibility of a suture had similar radiographic outcomes compared to suture button fixation devices in treating ankle syndesmotic instability. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.