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

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.

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Key information

Conditions

Lateral Ankle Instability

Age range

14 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MORE Foundation, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

Evaluate Effectiveness

Time frame: 12 weeks to last recorded follow-up

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.
Evaluate Safety

Time frame: 2 weeks to last recorded follow-up

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.

Sponsors and collaborators

Lead sponsor

Stryker Trauma and Extremities

Industry

Registry information

Official study title

An Open Label, Single Cohort, Multi-center, Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Feb 17, 2025
Registry last updated: Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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