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

NCT ID: NCT05062265

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Tight Rope Fixation

Group Type: ACTIVE_COMPARATOR

Tight rope fixation

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

Tight rope fixation

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arthrex, Inc.

INDUSTRY

Sponsor Role: collaborator

Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists

OTHER

Sponsor Role: lead

Responsible Party

Blake E. Moore, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Blake E Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists

Ashley Suttmiller, PhD

Role: STUDY_CHAIR

Clinical Researcher

Brice A Snyder, MSAT

Role: STUDY_DIRECTOR

Director of Clinical Research

Locations

Atlantic Orthopaedic Specialists

Virginia Beach, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AOS-0001

Identifier Type: -

Identifier Source: org_study_id