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

NCT06638138 | Completed FDA Device

• 1 other identifier: ART-003
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Lateral Ankle Instability

Keywords

ATFL reconstructive procedure; Flexband; modified Bröstrom reconstruction

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint

  The primary outcome measure will be subject reported assessment of time to pre-injury activity level.

  From 2 weeks post-surgery to 26 weeks post-surgery.

• Primary Safety Endpoint

  The primary safety endpoints listed below will be recorded as adverse events and qualified as to whether they are procedure or product related. • Adverse Events related to the procedure including: * Delayed wound healing (4wks post-surgery) * Wound infection (superficial or deep) * Neuritis (persistent 6wks post-surgery) * Peri-implant osteolysis * Reoperations of the index ankle * Revisions of the ligament repair Additionally, complications necessitating a return to OR due to implant failure, foreign body reaction, or deep wound infection will be captured and characterized.

  Time of surgery to 2 years post-surgery

Secondary Outcomes (11)

• Physician Assessment of Healing

  From 2 weeks post-surgery to 26 weeks post-surgery

• Anterior Drawer Assessment

  From 2 weeks post-surgery to 26 weeks post-surgery

• Talar Tilt Assessment

  From 2 weeks post-surgery to 26 weeks post-surgery

• Pain Medication Usage

  From 2 weeks post-surgery to 26 weeks post-surgery

• FAAM

  From 2 weeks post-surgery to 26 weeks post-surgery

Study Arms (2)

FLEXBAND

ACTIVE COMPARATOR

This group will undergo a lateral ankle ligament repair using the modified Broström technique with Artelon FLEXBAND augmentation of the ATFL.

Device: Flexband

Control

NO INTERVENTION

This group will undergo a lateral ankle ligament repair using the modified Broström technique. This technique utilizes anchors to repair the ATFL, in some cases the CFL, lateral ankle capsule and extensor retinaculum. This will be done without Artelon FLEXBAND augmentation.

Interventions

Flexband DEVICE

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.

FLEXBAND

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• 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.
• Subjects undergoing a Calcaneal osteotomy.
• Subjects requiring major additional tendon surgery (i.e., peroneal tendon repair or tenodesis).
• Neuropathy.
• Subjects with diabetes, who, in the opinion of the investigator, are not sufficiently controlled.
• BMI greater than 40 kg/m2.
• Subjects with active Worker's Compensation Cases
• Any subject with a history of infection of the ankle predating the ankle repair.
• Subjects with a systemic ligament laxity disorder (i.e., Ehlers-Danlos Syndrome).
• Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures.
• Subjects who have a medical history that would likely make the subject an unreliable research participant.
• Subjects that are nursing or pregnant at the time of surgery.
• Subjects with physician assessed untreated alcohol or substance abuse at the time of screening.
• Subjects who are currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening.

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (8)

MORE Foundation

Phoenix, Arizona, 85023, United States

Location

University of Florida

Gainesville, Florida, 32607, United States

Location

Southeast Orthopedic Specialists

Jacksonville, Florida, 32204, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Orthopedic Foot and Ankle Center

Worthington, Ohio, 43085, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

UT Health Houson

Houston, Texas, 77030, United States

Location

The Center for Advanced Orthopedics

Falls Church, Virginia, 22042, United States

Location

Study Officials

• Rebecca Gibson

  Stryker Trauma & Extremities

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: October 15, 2024
• Study Start: August 22, 2023
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)