The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after open non-augmented Broström repair or open Broström repair augmented with the BioBrace Implant.
Age 18-65 years
Chronic lateral ankle instability (>3 months) confirmed by clinical examination (positive anterior drawer test or talar tilt >10°) and imaging (stress X-ray or MRI).
No prior ankle surgery on the affected limb.
Willingness to follow postoperative visits and rehabilitation protocols and filling out the patient reported outcome measures (PROMs) forms.
BMI>40
Significant secondary procedures done at the time of repair, including micro-fracture, or any other treatment of osteochondral lesions of the talus or tibia.
Concomitant deltoid ligament insufficiency.
Any worker's compensation case or any subject with a history of infection of the ankle predating the ankle repair. Current orthopedic issues, not related to the ankle, that prevented the patient from performing the functional tests.
Parallel
Standard Brostrom Repair
Procedure/SurgeryStandard-of-care Brostrom repair for chronic lateral ankle instability
Brostrom repair with augmentation
DeviceBrostrom repair with BioBrace
Pain VAS
The pain VAS (Visual Analog Scale) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients. It consists of a line marked from 0 to 10, with 0 representing "no pain" at one end and 10 "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 10.
PROMIS Scale v2.0 - Pain Intensity 3a
The PROMIS Scale v2.0 - Pain Intensity 3a scale utilizes a 3-question questionnaire to assess patients' pain experiences over the previous 7 days. The items include the intensity of pain at its worst, the intensity of pain on average, and the level of pain right now. The items are scored on a scale from "Had no pain" to "Very severe".
NIH Toolbox Pain Interference CAT Ages 18 v3.0
The NIH Toolbox Pain Interference CAT Ages 18 v3.0 is a computerized adaptive test that evaluates how much pain has interfered with and affected a person's life and daily activities over the previous 7 days. The questions are generated dynamically based on previous answers. Results are reported as a T-score. A higher T-score indicates a greater degree of pain interference.
PROMIS Scale v1.2 - Global Mental 2a
The PROMIS Scale v1.2 - Global Mental 2a is a two-question questionnaire assessing participants' mental health, mood, ability to think, and satisfaction with social activities and relationships. The questions are scored from "Excellent" to "Poor".
Return to Activity
Participants will fill out biweekly (2 weeks) surveys assessing their participation in any physical activities or sport, participation in their primary physical activities or sport, how often and how long they participated, their performance in those activities, and their own subjective understanding of why their performance may be different than before their injuries.
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Massachusetts General Hospital
Lead sponsor
CONMED Corporation
Collaborator
