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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-22

Study Completion Date

2027-06-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Lateral Ankle Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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FLEXBAND

This group will undergo a lateral ankle ligament repair using the modified Broström technique with Artelon FLEXBAND augmentation of the ATFL.

Group Type ACTIVE_COMPARATOR

Flexband

Intervention Type DEVICE

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.

Control

This 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Flexband

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No