Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT03472404
Eligibility Criteria:
Inclusion Criteria:
* patients diagnosed with chronic lateral ankle instability (multiple ankle inversion trauma within 12 months and symptoms present \>1 year). Lateral ankle instability is present if the patient complains of giving way of the ankle and has positive signs of ankle instability during physical exam (talar tilt score of \>15 degrees compared to contralateral ankle or anterior drawer test score of \>10mm compared to the contralateral ankle.
* Conservative therapy has failed.
* Normal foot and ankle anatomy as determined by orthopedic surgeon.
* Patients in whom their ankle symptoms interfere with their physical activities.
* Patients with isolated anterior talofibular ligament which is indicated for repair using the Brostrom-Gould technique.
* BMI ≤30
* Patients who are able and willing to undergo ankle surgery.
* Patients who are able and willing to comply with the rehabilitation protocol in any of the study physiotherapy centers.
* Patients who are able and willing to return for follow-up evaluations.
* Patients with sufficient understanding of the Dutch language.
Exclusion Criteria:
* Patients who need concomitant ankle surgery (i.e. Calcaneofibular ligament reconstruction, peroneus tendon repair, arthroscopy of the ankle, etc).
* Patients with comorbidities, including musculoskeletal injuries or diseases in other joints than the affected ankle which limits their physical activity.
* Ankle instability due to abnormal foot and ankle anatomy.
* No objective or subjective ankle instability.
* Previous ankle surgery.
* Patients in which the contralateral ankle also shows lateral ankle instability.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT03472404
Study Brief:
Protocol Section:
NCT03472404