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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT01109303
Eligibility Criteria:
Inclusion Criteria:
* men or women ≥ 18 years-old;
* ankle fracture type 44-C (AO classification) with an AP, lateral and mortise X-ray views of the ankle and an AP and lateral X-ray views of the leg;
* open fractures (Gustilo I-IIIb) or closed;
* trauma-surgery delay of less than 7 days;
* consent form signed.
Exclusion Criteria:
* ankle fractures without syndesmotic lesion;
* fracture associated with neuro-vascular lesions (Gustillo IIIc);
* pathologic fracture;
* fracture in a polytraumatized patient;
* fracture of a bone in the ipsilateral leg;
* men or women \> 65 years-old;
* chronic cardiac insufficiency (ejection fraction \< 30%);
* lower leg chronic venous insufficiency;
* neuro-arthropathic foot (Charcot, diabetes, etc…);
* body mass index ≥ 40;
* past medical history of fracture of the same ankle;
* medical conditions too serious for a surgery;
* men or women unfit to consent;
* any other conditions that make the examinator thinks that the follow up would be problematic.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01109303
Study Brief:
Protocol Section:
NCT01109303