Trials / Recruiting

RecruitingNCT07401095

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 40 (estimated)

Sponsor: Hancock Orthopedics · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
DEVICE	Brostrom repair with augmentation	Brostrom repair with BioBrace
OTHER	Brostrom repair without augmentation	Brostrom repair without BioBrace

Timeline

Start date: 2025-12-08
Primary completion: 2028-06-01
Completion: 2028-12-01
First posted: 2026-02-10
Last updated: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT07401095. Inclusion in this directory is not an endorsement.