RecruitingNot ApplicableNCT07401095

BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair

Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study

Sponsor

Hancock Orthopedics

Enrollment

40 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

ATFL Lateral Ankle Instability Anterior Talofibular Ligament Anterior Talofibular Ligament Injury Brostrom Procedure Brostrom Ankle

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria8

Previous Brostrom surgery.
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.
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.
History of non-compliance with medical treatment or clinical trial participation.
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.
Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study.
Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)

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