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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT02998333
Eligibility Criteria:
Inclusion Criteria:
* Patients are 18 years or older;
* Experience pain and/or a sensation of instability during sports and/or daily activity;
* Isolated lateral ankle instability;
* Planned for surgical repair of the ATFL;
* At least one previous episode of an ankle inversion sprain;
* Complaints for at least 6 months;
* Failed previous conservative treatment.
Exclusion Criteria:
* Serious concomitant injury (like arthrosis, ruled out using an AP and lateral x-ray according to standard protocol);
* Foot or ankle fracture in past;
* Previous foot or ankle surgery;
* ROM restriction of \>10 degrees;
* Medial instability;
* Severe misalignment;
* Ankle/foot deformities (e.g. severe flat foot);
* Systemic comorbidity leading to delayed recovery (e.g. Diabetes Mellitus, Rheumatoid Arthritis)
* (general) Hyper laxity
* Inability or unwillingness to provide consent
* Present factors that may cause difficulty of follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02998333
Study Brief:
Protocol Section:
NCT02998333