Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.

Completed · Not applicable

Conditions studied: Syndesmotic Injuries, Ligament Rupture, Bimalleolar Fractures, Trimalleolar Fractures

In brief

Over the course of a year from the start of the research study, twenty subjects will be randomized evenly into one of two groups after an informed consent is obtained: a traditional tight rope fixation group or a tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace group. Postoperative reduction was assessed by 3D volumetric ratios and measured by weight-bearing CT at 6-weeks and 3-months post-operation. Patient Reported Outcomes (PROs) were collected preoperatively, and at 6-weeks, 3-months, 6-months, and 1-year post-operation and included the Foot and Ankle Outcome Score and the 36-Item Short Form Survey Instrument (RAND-36) . Differences in volumetric ratios and PROs were evaluated between groups and time periods.

Key facts

Study ID

NCT05062265

Run by

Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists

People needed

23

Starts

2022-01-31

Expected to finish

2023-12-31

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• patients who fit the study injury list

You may not qualify if…

• smokers
• prior surgery on ankle
• bi-lateral surgery
• recent participation in another study within the last 90days

Where it is running

• Atlantic Orthopaedic Specialists — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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