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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT01051869
Eligibility Criteria:
Inclusion Criteria:
* Men or women aged 16 to 60 years of age
* Displaced, distal humerus fracture (OTA 13A or 13C) as seen in radiographs
* Fractures ≤ 28 days post injury
* Closed fractures
* No history of previous ulnar neuropathy or elbow pathology
* Provisin of informed consent
Exclusion Criteria:
* Vascular injury
* History of previous ulnar neuropathy or elbow pathology
* Fractures more than 28 days post-injury
* Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery
* Inability to comply with rehabilitation or form completion
* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT01051869
Study Brief:
Protocol Section:
NCT01051869