Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study
Hancock Orthopedics
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.
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), a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. At least 18 years of age at the time of surgery. 2. Able to read, understand and sign the informed consent form. 3. Willing to be available to attend each protocol required visit and complete the study required questionnaires. 4. Scheduled to undergo primary, arthroscopic Brostrom repair. Exclusion Criteria: 1. Previous Brostrom surgery. 2. 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. 3. Currently participating or plans to enroll in anot…
Interventions
- DeviceBrostrom repair with augmentation
Brostrom repair with BioBrace
- OtherBrostrom repair without augmentation
Brostrom repair without BioBrace
Location
- Hancock OrthopedicsGreenfield, Indiana