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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT05087667
Eligibility Criteria:
Inclusion Criteria:
* patient with femoral or humeral fracture requiring the installation of one or more cerclage(s) and respecting at least one of the criteria below:
* Primary femoral or humeral fractures (diaphyseal, metaphyseal, epiphyseal proximal or distal) with osteosynthesis by plate and screw or osteosynthesis by Intramedullary nailing associated with the installation of one or more cerclage(s)
* Patients with traumatic fracture of femur or humerus that required prosthetic rehabilitation associated with the installation of one or more cerclage(s)
* Peri-prosthetic fracture of the femur or humerus
* Resumption of prosthesis (hip, knee, shoulder, elbow) requiring the installation of one or more cerclages
* who underwent fixation with cerclage wiring (Sterile Self Locking Polymer Cerclage System or other cerclage systems used in standard care)
* age ≥18 years
* Who have given free, informed and written consent to participate in the study
* Patient able to communicate in French
* Patient affiliated to a social security system or entitled to a social security system
Exclusion Criteria:
* high-energy injury,
* associated damage to other long bones,
* fracture extension to the articular surface with displacement
* Severe disease that could interfere with the study results or be life threatening
* Patients with an infection
* Allergy to any component of the medical products
* Pregnant or breastfeeding women
* Anticipated unavailability during the study
* Participation in a clinical trial within 3 months prior to the inclusion visit.
* Patient with linguistic or psychological incapacity to understand and sign the informed consent.
* Patient deprived of liberty by administrative or judicial decision, or being under guardianship.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05087667
Study Brief:
Protocol Section:
NCT05087667