Actively Recruiting
BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
Led by Hancock Orthopedics · Updated on 2026-02-12
40
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
H
Hancock Orthopedics
Lead Sponsor
C
CONMED Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at the time of surgery
- Able to read, understand, and sign the informed consent form
- Willing to attend all required study visits and complete questionnaires
- Scheduled to undergo primary, arthroscopic Brostrom repair
You will not qualify if you...
- Previous Brostrom surgery
- Any additional procedures that would change post-operative recovery (e.g., total ankle replacement, OCD repair, foot/ankle osteotomies)
- Participation in another clinical trial affecting study outcomes
- History of non-compliance with medical treatment or clinical trials
- Physical or mental conditions impairing ability to comply with follow-up
- Females who are pregnant, breastfeeding, or planning pregnancy during study
- Any condition making the patient a poor surgical candidate
- Allergy to investigational device materials including bovine collagen, PLLA, or PEG
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hancock Orthopedics
Greenfield, Indiana, United States, 46140
Actively Recruiting
Research Team
J
Jay Badell, DPM, MS, FACFAS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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