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ENROLLING BY INVITATION
NCT06638138
NA

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2023-08-22

Completion Date

2027-06-23

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

DEVICE

Flexband

Artelon FLEXBAND is a commercially available, polycaprolactone polyurethane urea (PCL/PUUR) multipolymer synthetic knitted mesh that is used for soft tissue reinforcement procedures. The device is biocompatible and degradable and has been used as an augmentation device in over 50,000 Orthopedic tendon and ligament reconstructive procedures. The FLEXBAND kits contain the device and all of the instrumentation needed to insert the device.

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