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New mesh may speed recovery from ankle instability surgery

NCT ID NCT06638138

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study tested whether adding a synthetic mesh called Artelon FLEXBAND to standard ankle ligament surgery helps people with chronic ankle instability return to their normal activities sooner. Fifty-eight adults undergoing a modified Bröstrom procedure were randomly assigned to receive the mesh or surgery alone. Researchers tracked healing, safety, and function for up to two years after surgery.

What this could mean

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

Active substance
Artelon FLEXBAND (a synthetic, degradable mesh used to reinforce ligament repair)
What this could lead to
If successful, this device could help people with chronic ankle instability return to their normal activities faster after surgery.
What could go wrong
This is a small, completed trial with only 58 participants, so results may not apply to everyone. Risks include infection, delayed healing, or need for additional surgery.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

58 people

The number who actually took part.

Started

Aug 2023

Finished

Dec 2025

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.

Ages

18 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: 1. Subjects between and including the age of 18-75 at the time of surgery. 2. Subjects who were diagnosed with lateral ankle instability by physician clinical assessment. 3. Subjects who will undergo a modified Bröstrom procedure for an ATFL repair with or without FLEXBAND augmentation device (does not require an isolated repair). 4. Subjects that are able to understand, complete and sign the Consent Form. Exclusion Criteria: 1. 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). 2. 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. 3. Subjects undergoing a Calcaneal osteotomy. 4. Subjects requiring major additional tendon surgery (i.e., peroneal tendon repair or tenodesis). 5. Neuropathy. 6. Subjects with diabetes, who, in the opinion of the investigator, are not sufficiently controlled. 7. BMI greater than 40 kg/m2. 8. Subjects with active Worker's Compensation Cases 9. Any subject with a history of infection of the ankle predating the ankle repair. 10. Subjects with a systemic ligament laxity disorder (i.e., Ehlers-Danlos Syndrome). 11. Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures. 12. Subjects who have a medical history that would likely make the subject an unreliable research participant. 13. Subjects that are nursing or pregnant at the time of surgery. 14. Subjects with physician assessed untreated alcohol or substance abuse at the time of screening. 15. Subjects who are currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • MORE Foundation

    Phoenix, Arizona, 85023, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • OrthoCarolina Research Institute

    Charlotte, North Carolina, 28207, United States

  • Orthopedic Foot and Ankle Center

    Worthington, Ohio, 43085, United States

  • Southeast Orthopedic Specialists

    Jacksonville, Florida, 32204, United States

  • The Center for Advanced Orthopedics

    Falls Church, Virginia, 22042, United States

  • UT Health Houson

    Houston, Texas, 77030, United States

  • University of Florida

    Gainesville, Florida, 32607, United States

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