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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07365202
Eligibility Criteria:
Inclusion Criteria:
* Adult patient at the time of injury
• Patient who underwent surgery with a low-profile plate, including:
* Isolated lateral malleolar fracture treated with a low-profile anatomical plate
* Lateral malleolar fracture associated with a bimalleolar injury treated with a low-profile anatomical plate
* Lateral malleolar fracture associated with a trimalleolar injury treated with a low-profile anatomical plate
* Lateral malleolar fracture associated with a tibial pilon injury treated with a low-profile anatomical plate
* Standard preoperative radiographs (ankle AP and lateral views)
* Standard postoperative radiographs (ankle AP and lateral views)
* No objection to participation in the study
Exclusion Criteria:
* Individuals deprived of liberty by judicial or administrative decision, or individuals under legal protection
* Patients with dementia preventing the collection of secondary clinical outcome measures (Olerud and Molander score, VAS, EFAS score, EQ-5D-5L)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT07365202
Study Brief:
Protocol Section:
NCT07365202