The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures: Patient-Reported Functional Outcome and Radiological Stability Measurements; a Clinical Trial Protocol

A total of 120 patients with Lauge Hansen SER 4B ankle fractures will be randomised (1:1 ratio) to conventional plating of the lateral malleolus only or additional suture of the deep deltoid ligament. The primary end point was patient-reported function measured in Olerud-Molander Ankle Score (OMAS) at 1 and 2 years. The secondary end points included Self-Reported Foot and Ankle Score (SEFAS), Ankle Fracture Outcome of Rehabilitation Measure (A-FORM), VAS pain, and EuroQol-5D-5L scores; rates of treatment-related adverse events, reoperations, and incidence of posttraumatic arthritis; and comparison of side-to-side differences in tibiotalar medial clear space from bilateral weightbearing ankle radiographs and gravity stress on group level.