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| Name | Class |
|---|---|
| CONMED Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - Repair Only Group | Sham Comparator | Procedure: Standard of care Brostrom repair. |
|
| BioBrace Augment Group | Experimental | Brostrom repair with BioBrace |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brostrom repair with augmentation | Device | Brostrom repair with BioBrace |
| |
| Measure | Description | Time Frame |
|---|---|---|
| American Orthopedic Foot and Ankle Society score (AOFAS) | 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 | Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months |
| Foot Function Index (FFI) | 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. | Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months |
| Visual Analog Scale (VAS) | 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. | Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months |
| Karlsson-Peterson score | 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. | Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jay Badell, DPM, MS, FACFAS | Contact | 317-477-6683 | JBadell@hancockhealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hancock Orthopedics | Recruiting | Greenfield | Indiana | 46140 | United States |
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1:1 randomization
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| Brostrom repair without augmentation |
| Other |
Brostrom repair without BioBrace |
|
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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