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 @ 4:45 AM
Ignite Modification Date:
2025-12-25 @ 4:45 AM
NCT ID:
NCT01363518
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of a closed, humeral shaft fracture
2. English Speaking
3. Age between 18-65 at the time of injury
4. Entry into the study within 2 weeks of injury
5. Available for follow-up for at least 12 months
6. Patient signs informed consent
Exclusion Criteria:
1. Age less than 18 or greater than 65 at time of injury
2. Patients who are skeletally immature
3. Humeral shaft fractures that extend into the articular surface
4. Open humeral shaft fractures
5. Additional long bone injuries of upper or lower extremity that would compromise outcome assessment
6. Vascular injury requiring repair
7. Pathologic fracture
8. Definitive treatment delay of more than 2 weeks from initial injury
9. Immunocompromised patient
10. Unable to comply with post-operative rehabilitation protocols or instructions
11. Current or impending incarceration
12. Unlikely to follow-up in surgeon's estimation
13. Pregnant or lactating female
14. Previous retained hardware in humeral shaft
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01363518
Study Brief:
Protocol Section:
NCT01363518