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.
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.
Previous Brostrom surgery.
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.
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.
History of non-compliance with medical treatment or clinical trial participation.
Parallel
Brostrom repair with augmentation
DeviceBrostrom repair with BioBrace
Brostrom repair without augmentation
Other interventionBrostrom repair without BioBrace
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
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.
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.
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.
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Hancock Orthopedics
Lead sponsor
CONMED Corporation
Collaborator
