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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT02390856
Eligibility Criteria:
Inclusion Criteria:
* Skeletally mature patients (18-80)
* Unstable AO Type A and C1 fractures
* Closed injuries, acute (\<14 days), displaced, and unstable
Exclusion Criteria:
* Patients under the age of 18 or over the age of 85 (if included in our analysis, these would likely be outliers in our patient population)
* Patients with documented complex regional pain syndrome (CRPS) or history of CRPS
* Patients with suspected or known allergies to titanium or nickel
* Patients who are non-English speakers
* Patients with open wound fractures
* Patients with inflammatory arthritis
* Patients with positive pregnancy test
* Additional musculo-skeletal injuries of the upper extremity would represent exclusion criteria (elbow fractures, scaphoid fractures, and contralateral wrist fracture).
* Previous major wrist injury or surgery (not including Carpal Tunnel, De Quervain's and trigger finger release)
* Patients with previously diagnosed metabolic bone disease, currently being treated.
* Non-English speaking patients (validated, translated questionnaires are not available)
* Patients needing ipsilateral concomitant operations that will have material impact on the study
* Patients with previous wrist fractures, prior wrist injury, stiffness, degenerative joint disease, or pain
* Previous minor surgery - for carpal tunnel, de Quervain's, ganglion, etc. - does not constitute exclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02390856
Study Brief:
Protocol Section:
NCT02390856