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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
Sponsor: Stryker Trauma and Extremities
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
Conditions
Interventions
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