Actively Recruiting
Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study
Led by Hancock Orthopedics · Updated on 2026-02-12
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
H
Hancock Orthopedics
Lead Sponsor
C
CONMED Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating patient outcomes and functional scores before and after an all-arthroscopic Brostrom repair for lateral ankle ligament injuries. This trial compares the use of a suture anchor construct alone versus suture anchors combined with the BioBrace Implant to understand differences in recovery and function. The study is prospective, randomized, and single-center, focusing on early postoperative results and safety. Participants will be assigned to one of two groups: a control group receiving the standard arthroscopic Brostrom repair using suture anchors only, and a treatment group receiving the same repair augmented with the BioBrace Implant. The procedures are performed using an all-arthroscopic Brostrom technique. Clinical evaluations are scheduled preoperatively and at multiple points postoperatively, including 1, 3, and 6 weeks, and 3, 6, and 12 months. During the study, participants will complete various patient-reported outcome measures to assess pain, function, activity levels, and safety following surgery. These assessments include the American Orthopedic Foot and Ankle Society score, Foot Function Index, Visual Analog Scale, and Karlsson-Peterson score at all scheduled visits. The study involves close monitoring from before surgery through one year after the procedure to track recovery and outcomes.
CONDITIONS
Brief 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 be available to attend each protocol required visit and complete the study required questionnaires
- Scheduled to undergo primary, arthroscopic Brostrom repair
You will not qualify if you...
- Previous Brostrom surgery
- Concomitant procedures that would change the post operative course/recovery (e.g. total ankle replacement, OCD repair, foot/ankle osteotomies)
- Currently participating or plans to enroll in another clinical trial that would affect outcomes
- History of non-compliance with medical treatment or clinical trial participation
- Physically or mentally compromised to the extent of inability to comply with follow-up
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Any comorbidity or condition making the patient a poor surgical candidate
- Hypersensitivity 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 weeks
Participants undergo arthroscopic Brostrom lateral ankle ligament repair with or without the BioBrace® Implant.
1 baseline visit (preoperative) and 3 visits at 1, 3, and 6 weeks post-surgery
Duration - Up to 12 months
Participants attend follow-up visits to assess pain, function, activity, and safety after surgery.
Visits at 3, 6, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
Hancock Orthopedics
Greenfield, Indiana, United States, 46140
Actively Recruiting
Research Team
J
Jay Badell, DPM, MS, FACFAS
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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