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Lateral Ankle InstabilityNCT06638138

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

A study testing Flexband in people with Lateral Ankle Instability, run by Stryker Trauma and Extremities at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lateral Ankle Instability
What is being tested?
Flexband
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
8 sitesUnited States
Study dates
22 Aug 2023to 3 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • OrthoCarolina Research Institute

    Charlotte, North Carolina, 28207

  • The Center for Advanced Orthopedics

    Falls Church, Virginia, 22042

  • University of Florida

    Gainesville, Florida, 32607

  • UT Health Houson

    Houston, Texas, 77030

  • Southeast Orthopedic Specialists

    Jacksonville, Florida, 32204

  • MORE Foundation

    Phoenix, Arizona, 85023

  • Orthopedic Foot and Ankle Center

    Worthington, Ohio, 43085

Other trials in United States

About this study

Official title: A Multi-center, Prospective, Blinded, Randomized Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability

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.

Being tested
Flexband
Keywords
ATFL reconstructive procedure, Flexband, modified Bröstrom reconstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FlexbandDevice

    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.

Study groups in NCT06638138
Study groupRoleWhat they receive
FLEXBANDActive comparatorThis group will undergo a lateral ankle ligament repair using the modified Broström technique with Artelon FLEXBAND augmentation of the ATFL.
Receives: Device: Flexband
ControlNo interventionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Efficacy Endpoint

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

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

  2. 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.

    Measured: Time of surgery to 2 years post-surgery

Secondary outcomes (11)

  1. Physician Assessment of Healing

    Subjects will complete post-surgery study follow-up visits during which time the physician assessment of healing will be completed.

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

  2. Anterior Drawer Assessment

    Subjects will complete post-surgery study follow-up visits during which time the anterior drawer assessment will be completed.

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

  3. Talar Tilt Assessment

    Subjects will complete post-surgery study follow-up visits during which time the talar tilt assessment will be completed.

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

  4. Pain Medication Usage

    Subjects will complete post-surgery study follow-up visits during which time the physician will document pain medication usage.

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

  5. FAAM

    The Foot and Ankle Ability Measure (FAAM) score is a percentage that indicates a patient's level of foot and ankle function. The FAAM is a survey that uses a 5-point Likert scale to score each item. The scale ranges from 4 for "no difficulty" to 0 for "unable to do". Patients can also select "not applicable" if the item doesn't apply to them.

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

  6. FFI

    The Foot Function Index (FFI) is a self-administered questionnaire that measures the impact of foot problems on a person's pain, disability, and activity restriction. The FFI uses a visual analog scale (VAS) to rate each item on a scale of 0 to 100, with higher scores indicating more pain, disability, or limitation.

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

  7. CAIT

    The Cumberland Ankle Instability Tool (CAIT) score is a number that indicates the severity of ankle instability. The CAIT score ranges from 0 to 30, with 30 being the best possible score and 0 being the worst.

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

  8. VAS Pain

    A VAS score is a measurement of pain intensity or other sensations and feelings using a visual analog scale. The VAS is scored by the following measures: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

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

  9. EQ-5D-5L

    Consists of a 5-question measure where patients rate their health today on a 5-point scale on a 5-dimension scale and a visual analogue scale to measure overall health status.

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

  10. Patient Satisfaction Scores

    A subjective questionnaire measuring patient satisfaction will be collected follow-up visits.

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

  11. FOTO

    A subset of study sites will additionally collect FOTO data. The Focus on Therapeutic Outcomes (FOTO) is a numerical value that measures a patient's functional ability. Scores range from 0 (low function) to 100 (high function).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start22 Aug 2023
  3. Primary completion3 Dec 2025
  4. Study completion3 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06638138
Sponsor's protocol ID
ART-003
Status last verified
Apr 2026
First submitted
5 Sep 2024
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Unknown at this time.

Questions about this trial

What is this clinical trial studying?

A study testing Flexband in people with Lateral Ankle Instability, run by Stryker Trauma and Extremities at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Efficacy Endpoint (time frame: From 2 weeks post-surgery to 26 weeks post-surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06638138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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