Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07401095

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Hancock Orthopedics

Greenfield, Indiana, United States, 46140

Actively Recruiting

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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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