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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT01134094
Eligibility Criteria:
Inclusion Criteria:
* Arbeitsgemeinschaft für Osteosynthesefragen (AO) type 44-B1 fibula fracture
* Patients aged between 18 and 65 inclusive.
* No talar shift - Medial clear space less than 2mm compared with the superior clear space on anterior-posterior (AP) view of the ankle.
* Closed injury
* No concurrent fractures/dislocations
* Mobilising unaided/independently pre-injury
* Willingness to be followed up for 12 months
* Able to provide informed written consent
Exclusion Criteria:
* Medically fit for general anaesthesia/surgery
* Dislocation on presentation
* Skeletally immature patients
* Previous trauma or surgery to the affected ankle
* Pregnancy
* Other injuries that impede mobilisation e.g. stroke, neurovascular deficit at presentation
* Non-English speaking
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01134094
Study Brief:
Protocol Section:
NCT01134094