WRx Distal Radius Wrist Fracture Study
This study has been terminated.
(Funding was withdrawn due to inadequete enrollment.)
Information provided by:
First received: February 4, 2011
Last updated: January 23, 2012
Last verified: January 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?
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Change in Pain (to no pain) [ Time Frame: Baseline to week 52 after surgery ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Change in range of motion measurements [ Time Frame: Basline to week 52 after surgery ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Measurements of grip and pinch strength will be taken using a pinch gauge and a dynamometer.
|Study Start Date:||February 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Procedure: Surgical treatment of distal radius fractures
Surgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate
Contacts and Locations