Ankle, Anterior Talofibular Ligament, ATFL, Bioinductive Implant, Brostrom Procedure, Chronic Lateral Ankle Instability, Lateral Ankle Instability
Conditions
Keywords
Lateral Ankle Instability, Brostrom Repair, Bioinductive Implant, ATFL, Anterior Talofibular Ligament, Brostrom Procedure, Ankle Surgery, Ankle
Brief summary
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.
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 the Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms: Control Group: Open standard Broström repair of the lateral ankle Treatment Group: Open Broström repair of the lateral ankle using a suture-anchor construct augmented with the BioBrace® Implant. Both groups will be immobilized for 2 weeks and then will undergo standard accelerated rehabilitation protocols (early weight-bearing and sport-specific training) unless they are not tolerated which will lead to using traditional standard protocols. Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 2 weeks, 2 months, 6 months, and 12 months using various patient-reported outcome measures to asses pain, function, satisfaction, activity and safety post surgery. Participants will also receive biweekly (every 2 weeks) electronic questionnaires assessing return to sport and return to daily/recreational activity. These biweekly assessments will continue until the participant reports full return to their preoperative level of activity or sport. Participants who do not reach preoperative activity/sport level will continue receiving biweekly questionnaires through the 1 year final visit.
Interventions
PROCEDUREStandard Brostrom Repair
Standard-of-care Brostrom repair for chronic lateral ankle instability
Brostrom repair with BioBrace
Sponsors
Massachusetts General Hospital
CONMED Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Concomitant osteochondral lesions, significant degenerative changes, or severe varus/valgus deformity, neuromuscular disorders or non-adherence concerns. * Pregnant * Diagnosis of Ehlers-Danlos Syndrome or other connective tissue / hyperlaxity disorder. * Prior revision ankle ligament surgery on the affected limb (any revision Broström or lateral ligament reconstruction).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain VAS | From 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 3a | From 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 v3.0 | From 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 2a | From 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 2a | From 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 Scored | From 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 Assessment | From 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Return to Activity | From baseline until participants report full return to activity or until last follow-up at 12 months. | 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. |
Countries
United States
Contacts
CONTACTSoheil Ashkani-Esfahani, MD MPH
Outcome results
None listed