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

NCT06829667 | Completed FDA Device

• 1 other identifier: ART-004
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Lateral Ankle Instability

Keywords

ATFL reconstructive procedure

Outcome Measures

Primary Outcomes (2)

• Evaluate Effectiveness

  The overall objective of this study is to evaluate the effectiveness and safety of suture tape when used as an augmentation device during surgical reconstruction of ATFL in patients suffering lateral ankle instability. The assessment of effectiveness will be measured by the rate of complications as defined by those patients that necessitated a return to the OR, including implant failure, symptomatic implant requiring removal, peri-implant fracture, deep wound infection and foreign body reaction.

  12 weeks to last recorded follow-up

• Evaluate Safety

  The overall objective of this study is to evaluate the effectiveness and safety of suture tape when used as an augmentation device during surgical reconstruction of ATFL in patients suffering lateral ankle instability. Safety of study subjects will be established by recording treatment, incidence and frequency of adverse events. Also, adverse events will be classified as procedure related and/or product related.

  2 weeks to last recorded follow-up

Interventions

Arthrex InternalBrace DEVICE

Arthrex InternalBrace is composed of a polyethylene/polyester suture tape and knotless bone anchors to provide ligament repair bridging and reinforce ligament strength. There have been conflicting results surrounding the clinical efficacy of its use in lateral ligament reconstruction.

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 75 subjects underwent an ATFL repair with Arthrex InternalBrace

You may qualify if:

• 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)

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 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

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (4)

MORE Foundation

Phoenix, Arizona, 85023, United States

Location

KUMC

Kansas City, Kansas, 66103, United States

Location

Seaview Orthopaedics

Ocean City, New Jersey, 07712, United States

Location

ERLANGER

Chattanooga, Tennessee, 37403, United States

Location

Study Officials

• Rebecca Gibson

  Stryker Trauma & Extremities

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: October 13, 2023
• Primary Completion: April 8, 2026
• Study Completion: April 8, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)