WRx Distal Radius Wrist Fracture Study
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|ClinicalTrials.gov Identifier: NCT01293227|
Recruitment Status : Terminated (Funding was withdrawn due to inadequete enrollment.)
First Posted : February 10, 2011
Last Update Posted : January 24, 2012
This research project is a multi-year proposal, with the goals of answering and evaluating the following:
- Does an intramedullary locking device applied in an extra-articular distal radius fracture improve post operative pain, diminish hospitalization, improve early return to activity and function compared to a volar locked plate?
- Does an intramedullary locking device applied in an extra-articular distal radius fracture improve patient related outcome measures compared to a volar locked plate?
|Condition or disease||Intervention/treatment||Phase|
|Wrist Fracture||Procedure: Surgical treatment of distal radius fractures||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Intramedullary Locked Nail Versus Volar Locked Plating in the Treatment of Extra-articular and Minimally Displaced Intra-articular Distal Radius Fractures: A Prospective Randomized Trial.|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Procedure: Surgical treatment of distal radius fractures
- Change in Pain (to no pain) [ Time Frame: Baseline to week 52 after surgery ]Postoperative pain will be monitored by recording of the consumption of narcotic pain medications converted to morphine equivalents. Participants will record medications taken in a Pain Diary. They will also be asked to complete a Visual Analog scale questionnaire regarding their pain.
- Change in range of motion measurements [ Time Frame: Basline to week 52 after surgery ]Range of motion measurements will be measured using a goniometer and moving the hand and wrist into specific postitions.
- Grip and Pinch [ Time Frame: Baseline to week 52 after surgery ]Measurements of grip and pinch strength will be taken using a pinch gauge and a dynamometer.
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): NCT01293227
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Alexander Shin, MD||Mayo Clinic|