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

NCT05062265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-02-19

Study results available
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Summary

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.

Conditions

  • Syndesmotic Injuries
  • Ligament Rupture
  • Bimalleolar Fractures
  • Trimalleolar Fractures

Interventions

DEVICE

Tight rope fixation

a traditional tight rope fixation is performed on one randomized set of subjects

DEVICE

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

A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace set of subjects to compare syndesmotic volume

Sponsors & Collaborators

  • Arthrex, Inc.

    collaborator INDUSTRY

  • Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists

    lead OTHER

Principal Investigators

  • Blake E Moore, MD · Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists

  • Ashley Suttmiller, PhD · Clinical Researcher

  • Brice A Snyder, MSAT · Director of Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05062265 on ClinicalTrials.gov