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Ankle tape study shows promise for chronic instability

NCT ID NCT06829667

Disease control Sponsor: Stryker Trauma and Extremities Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This study looked back at medical records of 103 people who had surgery for chronic ankle instability. Surgeons used a special suture tape (Arthrex InternalBrace) to reinforce the repaired ligament. The goal was to see how safe and effective the tape is by tracking complications like implant failure or infection. Results could help doctors decide if this device is a good option for ankle ligament repair.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Arthrex InternalBrace (suture tape and bone anchors)
What this could lead to
If successful, this could confirm that suture tape is a safe and effective option for repairing ankle ligaments, helping people with chronic ankle instability.
What could go wrong
This is a small, retrospective review, not a controlled trial, so results may be less reliable. The device has shown mixed results in past studies, and complications like implant failure or infection are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

103 people

The number who actually took part.

Started

Oct 2023

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Approximately 75 subjects underwent an ATFL repair with Arthrex InternalBrace

Ages

14 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lateral ankle instability

Contacts and locations

Locations

  • ERLANGER

    Chattanooga, Tennessee, 37403, United States

  • KUMC

    Kansas City, Kansas, 66103, United States

  • MORE Foundation

    Phoenix, Arizona, 85023, United States

  • Seaview Orthopaedics

    Ocean City, New Jersey, 07712, United States

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