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The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures: Patient-Reported Functional Outcome and Radiological Stability Measurements; a Clinical Trial Protocol
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The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures: Patient-Reported Functional Outcome and Radiological Stability Measurements; a Clinical Trial Protocol
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Journal Article
The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures: Patient-Reported Functional Outcome and Radiological Stability Measurements; a Clinical Trial Protocol
2025
Overview
Background:
Suturing the deep posterior deltoid ligament in unstable ankle fractures is novel to established treatment. Some cadaveric and clinical trials support that adding deltoid ligament repair to plating of the lateral fracture will improve stability restoration.
Objectives:
We will investigate the effects of deep deltoid ligament repair on patient-reported function, radiologic stability parameters, and the incidence of ankle osteoarthritis and the possible side effects from this additional procedure. The medial ankle injury patterns found will be described.
Study design:
A randomised controlled nonblinded multicentre trial.
Methods:
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.
Graphical Abstract
Publisher
SAGE Publications,Sage Publications Ltd,SAGE Publishing
Subject
