BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair

Hancock Orthopedics

Status: Enrolling

Conditions: Brostrom Procedure; Anterior Talofibular Ligament Injury; Anterior Talofibular Ligament; Lateral Ankle Instability; ATFL; Ankle; Brostrom

Treatments: Other: Brostrom repair without augmentation; Device: Brostrom repair with augmentation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07401095

ABBB

Details and patient eligibility

About

The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after an all-arthroscopic Brostrom repair using either a suture anchor construct alone or suture anchors with the BioBrace Implant.

Full description

This is a single-center, prospective, randomized (1:1) interventional study investigating the use of the BioBrace® Implant in lateral ankle ligament repair procedures performed using an all-arthroscopic Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms:

Control Group: Arthroscopic Broström repair using a suture-anchor construct only.

Treatment Group: Arthroscopic Broström repair using a suture-anchor construct augmented with the BioBrace® Implant.

Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 1, 3, and 6 weeks, as well as at 3, 6, and 12 months using various patient-reported outcome measures to asses pain, function, activity and safety post surgery.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. At least 18 years of age at the time of surgery.
2. Able to read, understand and sign the informed consent form.
3. Willing to be available to attend each protocol required visit and complete the study required questionnaires.
4. Scheduled to undergo primary, arthroscopic Brostrom repair.

Exclusion criteria

1. Previous Brostrom surgery.
2. Concomitant procedures that would change the post operative course/recovery (i.e. total ankle replacement, OCD repair, foot/ankle osteotomies) as determined by the Investigator.
3. Currently participating or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator.
4. History of non-compliance with medical treatment or clinical trial participation.
5. The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant with protocol required follow-up.
6. Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study.
7. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
8. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control - Repair Only Group

Sham Comparator group

Description:

Procedure: Standard of care Brostrom repair.

Treatment:

Other: Brostrom repair without augmentation

BioBrace Augment Group

Experimental group

Description:

Brostrom repair with BioBrace

Treatment:

Device: Brostrom repair with augmentation