Abstract
Research Type:
Level 1 - Randomized controlled trial (RCT), Meta-analysis of randomized trials with homogeneous results
Introduction/Purpose:
Distal ankle syndesmosis injuries cause persistent coronal instability of the tibiotalar joint, necessitating early stabilization. Traditional methods, including rigid screws or dynamic suture button systems, typically require at least 6 weeks of non-weight-bearing due to risks of screw breakage or instability. This study evaluates fracture reduction and outcomes in patients treated with a Syndesmosis Repair System, a dynamic screw system permitting early weight-bearing.
Methods:
A single-center phase 1 trial assessed the Fibulink dynamic screw in patients aged 22 years or older with ankle fractures requiring open reduction and internal fixation and concurring syndesmotic injury. Patients were randomly assigned to early weight-bearing at 4 weeks in a Controlled Ankle Motion (CAM) boot or standard non-weight-bearing for 6 weeks. Radiographs were evaluated for tibiofibular overlap, tibiofibular clear space, and medial clear space at regular intervals up to 6 months postoperatively. Postoperative complications, reoperations, and late-stage revisions, including device failure, were recorded.
Results:
A total of 37 patients were treated during the study period, with an average follow-up of 3.7 months (+/- 2.4 months). 18 patients were assigned to the 4-week weight-bearing group and 19 to the 6-week group. Both the early and late weight-bearing groups had similar Tibiofibular overlap (2.3 mm vs 2.6 mm, p=0.8241), tibiofibular clear space (4.5 mm vs 5.4 mm, p=0.078), and medial clear space (3.6 mm vs 3.4 mm, p=0.555) radiographic measurements, respectively. No reoperations, late-stage revisions, or significant complications, including device failure, were observed.
Conclusion:
The Syndesmosis Repair System provides effective stabilization of the distal tibiofibular joint, enabling earlier weight-bearing by up to 2 weeks without compromising fixation or requiring reoperation. Early (4 weeks) full weight-bearing for syndesmotic injuries fixed by flexible fixation should be recommended as part of the postoperative management.