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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT07067333
Eligibility Criteria:
Inclusion Criteria:
* Age: 10-16 years (skeletally immature, based on radiographic evidence of growth plates).
* Diagnosis: Closed or open (Grade I) diaphyseal femoral fractures.
* Fracture type: Simple transverse, short oblique, or spiral fractures (classified by the AO/OTA system or by the Müller classification).
Exclusion Criteria:
* • Fractures with significant comminution or open fractures (Grade II or III).
* Pathological fractures (e.g., secondary to bone disease).
* Severe systemic conditions that may affect bone healing or postoperative recovery (e.g., metabolic bone diseases).
* Patients with previous ipsilateral femur fractures or those requiring re-operation for non-union or malunion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
16 Years
Study:
NCT07067333
Study Brief:
Protocol Section:
NCT07067333