Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability

An Open Label, Single Cohort, Multi-center, Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability

NCT06829667•Stryker Trauma and Extremities

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Summary

This study is intended to be a retrospective chart review of patients with chronic ankle instability who have undergone a lateral ligament reconstructive procedure for ATFL repair (isolated or non-isolated) with suture tape augmentation. Patients that have been treated at any of the participating institutions that have undergone an ATFL reconstruction with Arthrex InternalBrace augmentation who have postoperative hospital or ASC records of safety and effectiveness as measured by adverse events, potential complications, and potential functional outcomes past the 10-week time point will be included.

Eligibility

Age

14 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients between and including the age of 14-75 at the time of surgery
•Patients who were diagnosed with lateral ankle instability by physician clinical assessment
•Patients who underwent an ATFL repair with Arthrex InternalBrace augmentation device (does not require an isolated repair)

Exclusion Criteria

•Significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol. (Minor microfractures and OCD lesions that do not warrant bone debridements, synovectomies, and bone spur removals are allowed)
•Any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an ATFL reconstructive procedure.
•Patients undergoing a Calcaneal osteotomy
•Patients with less than 6 weeks follow-up
•Patients with incomplete medical records
•Patients with Worker's Compensation Cases
•Any patient with a history of infection of the ankle predating the ankle repair
•Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures.
•Patients who have a medical history that would likely make the patient an unreliable research participant

Locations (4)

MORE Foundation

Phoenix, Arizona, United States

KUMC

Kansas City, Kansas, United States

Seaview Orthopaedics

Ocean City, New Jersey, United States

ERLANGER

Chattanooga, Tennessee, United States

Key Dates

Start Date

October 13, 2023

Primary Completion Date

December 30, 2025

Completion Date

December 30, 2025

Last Updated

September 10, 2025

Enrollment

ESTIMATED participants

Conditions

Lateral Ankle Instability

Interventions

Arthrex InternalBrace

DEVICE

Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability

NCT06638138

Lateral Ankle Instability

View study

WITHDRAWNNA

Modified Brostrӧm Procedure With and Without Possible Arthroscopy for Lateral Ankle Instability

NCT02470338

Lateral Ankle Instability

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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