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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT03689335
Eligibility Criteria:
Inclusion Criteria:
1. Fracture of the humeral shaft
2. Closed injury
3. Age ≥16 years
4. Able to provide informed consent in English
5. Surgery performed within 3 weeks of date of injury
Exclusion Criteria:
1. Completely undisplaced fractures
2. Injuries considered to be an absolute indication for surgery (including severe associated neurovascular injury, open fractures and bilateral injuries)
3. Patients with a periprosthetic or pathological fracture
4. Patients with an additional spine or limb injury (including those with polytrauma), which may impact upon functional rehabilitation
5. Patients medically unfit for surgery
6. Very frail patients (CSHA Clinical Frailty Score ≥6/9)
7. Pregnant women with predetermined treatment
8. Patients declining operative management
9. Patients unable to provide informed consent in English
10. Patients unable to comply with post-operative data gathering, including completing questionnaires in English
11. Non-residents, unable to return to the Unit for follow-up for a period of 1-year
12. Where the treating surgeon does not feel that inclusion in the trial is in the patient's best interests, either due to fracture pattern or patient factors
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT03689335
Study Brief:
Protocol Section:
NCT03689335