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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT01589692
Eligibility Criteria:
Inclusion Criteria:
* Patients who have an unstable DRF for which surgical fixation is indicated
o AO type A2, A3, C1, C2
* At least one of the following radiographic criteria indicating fracture instability
* Dorsal angulation of greater than 10°
* Radial inclination angle of less than 15°
* Radial shortening of greater than 3mm
* Patients with the ability to read and understand English (to complete study questionnaires)
* Community-dwelling patients
* Patients 60 years of age or older
Exclusion Criteria:
* Patients who have suffered open DRFs
* Patients with bilateral DRFs
* Patients with associated upper extremity fractures or ligament injuries (including ulnar styloid fracture, TFCC and wrist ligament injuries) requiring repair at the time of DRF fixation
* Multi-trauma patients
* Patients with prior DRF on the same wrist
* Patients with comorbid conditions prohibiting surgery
* Patients with neurologic disorders that affect hand, wrist or arm sensation or movement
* Patients who have a history of dementia, Alzheimer's Disease or other serious psychiatric disorders
* Patients with current substance abuse
* Patients who do not agree to be randomized
* Patients who have DRFs that are not equally suited for each procedure (i.e. severely comminuted fractures)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01589692
Study Brief:
Protocol Section:
NCT01589692