Distal Radius Fracture - Treatment Comparison
|ClinicalTrials.gov Identifier: NCT01883063|
Recruitment Status : Terminated (Low Enrollment)
First Posted : June 21, 2013
Last Update Posted : April 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Minimally Displaced Intra-articular Distal Radius Fracture||Device: Surgical Treatment Device: Non surgical Treatment (Cast or splint)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PATIENT OUTCOME COMPARISON OF INTRAMEDULLARY LOCKED NAILING VERSUS NONOPERATIVE MANAGEMENT OF EXTRA-ARTICULAR AND MINIMALLY DISPLACED INTRA-ARTICULAR DISTAL RADIUS FRACTURES IN THE ELDERLY|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: WRx™ Intramedullary Nail
Patients in this arm of the study will be treated with a minimally invasive WRx™ Intramedullary Nail for their wrist fracture.
Device: Surgical Treatment
Patients will be treated for distal radius fractures surgically with a WRx™ Intramedullary Nail
Active Comparator: Non surgical treatment (Cast)
Patients in this arm of the study will be treated with a cast for their wrist fracture.
Device: Non surgical Treatment (Cast or splint)
Patients will be treated for distal radius fractures non surgically with a cast or splint
- Change in Composite Patient Outcomes Over Time [ Time Frame: Data will be collected at 2, 6, 12, 26, 52 weeks ]Patient outcomes will be measured with the DASH, PRWE and a patient questionnaire.
- Change in Composite Functional Outcomes Over Time [ Time Frame: Data will be collected at 2, 6, 12, 26, 52 weeks ]Measurements of range of motion, strength and fracture healing will be used to determine functional outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883063
|United States, Illinois|
|Winfield, Illinois, United States, 60190|
|United States, Missouri|
|University of Missouri|
|Columbia, Missouri, United States, 65211|
|United States, Texas|
|John Peter Smith Hospital|
|Fort Worth, Texas, United States, 76107|