Ankle, Anterior Talofibular Ligament, Anterior Talofibular Ligament Injury, ATFL, Brostrom, Brostrom Procedure, Lateral Ankle Instability
Conditions
Keywords
BioBrace, The BioBrace Implant, BioBrace Implant, ATFL, Lateral Ankle Instability, CONMED, Ankle, Ankle Injury
Brief 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.
Interventions
Brostrom repair with BioBrace
OTHERBrostrom repair without augmentation
Brostrom repair without BioBrace
Sponsors
Hancock Orthopedics
CONMED Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator. 4. History of non-compliance with medical treatment or clinical trial participation. 5. The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant with protocol required follow-up. 6. Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study. 7. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator. 8. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foot Function Index (FFI) | Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months | The Foot Function Index (FFI) is a patient-reported questionnaire used to assess how foot conditions affect pain, disability, and activity limitation. It includes 23 items rated on a 0-10 scale, with higher scores indicating greater impairment in foot function. |
| Visual Analog Scale (VAS) | Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months | The Visual Analog Scale (VAS) is a tool used to measure the intensity of pain or other subjective symptoms. It consists of a 10-cm line labeled "no pain" at one end and "worst imaginable pain" at the other; patients mark their pain level on the line, which is then measured to provide a numerical score from 0 to 100. |
| American Orthopedic Foot and Ankle Society score (AOFAS) | Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months | The AOFAS Score is a clinician-based assessment tool that evaluates pain, function, and alignment in patients with foot and ankle disorders. It provides a composite score ranging from 0 to 100, with higher scores indicating better function. The system includes region-specific scales (e.g., ankle-hindfoot, midfoot, hallux) and combines both patient-reported symptoms and objective clinician findings |
| Karlsson-Peterson score | Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months | The Karlsson-Peterson Score is a functional ankle assessment tool that evaluates symptoms such as pain, swelling, instability, stiffness, stair-climbing ability, running ability, work/activity level, and need for support, producing a total score up to 100, with higher scores indicating better ankle function. |
Countries
United States
Contacts
CONTACTJay Badell, DPM, MS, FACFAS
Outcome results
None listed