Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
This study is looking at two ways to repair chronic lateral ankle instability (when your ankle frequently gives out or feels loose). One group will receive the standard Brostrom repair surgery. The other group will have the Brostrom repair augmented (strengthened) with a device called BioBrace®. Researchers want to see how well each method helps with pain and ankle function after surgery. You might be able to join if you are between 18 and 65 years old, have had chronic ankle instability for over three months, and haven't had previous ankle surgery on that ankle. The study is currently recruiting participants.
- Study design
- This is a single-center study that will randomly assign 75 participants to one of two treatment groups.
- What's involved
- You would have surgery, followed by immobilization for two weeks, and then rehabilitation. You would also attend follow-up visits and complete electronic questionnaires for up to 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after surgery to assess pain and other outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
At a glance
Conditions
Where it's being run
2 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
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What this trial measures
- Pain VASFrom enrollment to the last follow-up at 12 months
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 3aFrom enrollment to the last follow-up at 12 months.
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 v3.0From enrollment to the last follow-up at 12 months.
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 2aFrom enrollment to the last follow-up at 12 months.
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".
- PROMIS Scale v1.2 - Global Physical 2aFrom enrollment to the last follow-up at 12 months.
The PROMIS Scale v1.2 - Global Physical 2a is a two-question questionnaire designed to assess a participant's overall physical well-being. The participants are asked to rate their physical health on a scale from "Excellent" to "Poor" and their ability to carry out physical activities of daily living on a scale from "Completely" to "Not at all".
- Foot and Ankle Outcome Score (FAOS)From enrollment to the last follow-up at 12 months.
The Foot and Ankle Outcome Score (FAOS) is a 42-item questionnaire with 5 subscales: symptoms (5 items), stiffness (2 items), pain (9 items), daily living (17 items), sports and recreational activities (5 items), and quality of life (4 items). Each question is graded on a 5-point scale (none, mild, moderate, severe, and extreme problems).
- Foot and Ankle Ability Measure ScoredFrom enrollment to last follow-up at 12 months.
The Foot and Ankle Ability Measure Scored tool has two sections. The first section asks participants to rate their difficulty completing activities of daily living on a scale from "No difficulty" to "Unable to do" over 21 different questions along with a rating their current level of function from 0 to 100, with 100 being their prior level of function. The second section asks participants to rate their difficulty in participating in sports activities on a scale from "No difficulty at all" to "Unable to do" over 7 different questions along with a rating their current level of function during sport activities from 0 to 100, with 100 being their prior level of function.
- Clinical AssessmentFrom enrollment to the last follow-up at 12 months.
Clinicians will assess participants during their follow-up appointments. The clinicians will measure an anterior drawer test, range of motion assessment, hindfoot alignment, wound/incision assessment, complications assessment, and a physical activity assessment.