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

ENROLLING_BY_INVITATIONNA

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

A Multi-center, Prospective, Blinded, Randomized Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability

NCT06638138•Stryker Trauma and Extremities

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified Bröstrom reconstruction procedure for repair of the ATFL. Study participants undergoing ATFL reconstructive procedure using the ARTELON FLEXBAND System as an augmentation device will be compared to study participants undergoing a standard modified Bröstrom procedure alone. Clinician reported safety and functional outcomes measures will be collected at baseline; and at 2-, 6-, 12-, 18 and 26-weeks and 1- and 2-years post-surgery.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects between and including the age of 18-75 at the time of surgery.
•2. Subjects who were diagnosed with lateral ankle instability by physician clinical assessment.
•3. Subjects who will undergo a modified Bröstrom procedure for an ATFL repair with or without FLEXBAND augmentation device (does not require an isolated repair).
•4. Subjects that are able to understand, complete and sign the Consent Form.

Exclusion Criteria

•1. 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 major bone debridement, synovectomies, and bone spur/osteophyte removals are allowed).
•2. 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.
•3. Subjects undergoing a Calcaneal osteotomy.
•4. Subjects requiring major additional tendon surgery (i.e., peroneal tendon repair or tenodesis).
•5. Neuropathy.
•6. Subjects with diabetes, who, in the opinion of the investigator, are not sufficiently controlled.
•7. BMI greater than 40 kg/m2.
•8. Subjects with active Worker's Compensation Cases
•9. Any subject with a history of infection of the ankle predating the ankle repair.
•10. Subjects with a systemic ligament laxity disorder (i.e., Ehlers-Danlos Syndrome).
+5 more criteria

Locations (8)

MORE Foundation

Phoenix, Arizona, United States

University of Florida

Gainesville, Florida, United States

Southeast Orthopedic Specialists

Jacksonville, Florida, United States

OrthoCarolina Research Institute

Charlotte, North Carolina, United States

Orthopedic Foot and Ankle Center

Worthington, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

UT Health Houson

Houston, Texas, United States

The Center for Advanced Orthopedics

Falls Church, Virginia, United States

Key Dates

Start Date

August 22, 2023

Primary Completion Date

June 23, 2027

Completion Date

June 23, 2027

Last Updated

October 15, 2024

Enrollment

ESTIMATED participants

Conditions

Lateral Ankle Instability

Interventions

Flexband

DEVICE

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

NCT06829667

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: October 15, 2024Data 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.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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