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

Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists

Status: Completed

Conditions: Trimalleolar Fractures; Ligament Rupture; Syndesmotic Injuries; Bimalleolar Fractures

Treatments: Device: Tight rope fixation; Device: Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05062265

AOS-0001

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients who fit the study injury list

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups

Tight Rope Fixation

Active Comparator group

Treatment:

Device: Tight rope fixation

tight rope fixation w/ AITFL repair augmentation with an internal brace

Active Comparator group

Treatment:

Device: Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace