Early Motion After Volar Fixation for Distal Radius Fractures
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Early Motion After Volar Fixation for Distal Radius Fractures: A Prospective Trial|
- Wrist Motion [ Time Frame: 2 weeks - 1 year ] [ Designated as safety issue: No ]
- Patient Function [ Time Frame: 2 weeks - 1 year ] [ Designated as safety issue: No ]
- Patient Pain [ Time Frame: 2 weeks - 1 year ] [ Designated as safety issue: No ]
- Fracture reduction [ Time Frame: 2 week - 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Early motion
This group of patients will begin wrist motion 1 week after surgery.
Other: Early motion
One set of patients will begin wrist motion at 1 week after surgery.
Active Comparator: Immobilization
This group will be casted for 6 weeks after surgery
This set of patients will be casted for 6 weeks after surgery.
Many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist motion. Early motion is generally prescribed in the belief that it will result in greater final motion without compromising fixation. However, studies have failed to demonstrate clinically significant improvement in final wrist motion (>1 year follow up) compared to treatments requiring longer immobilization such as external fixation or bridge plating (McQueen 1996, Handoll 2003, Atroshi 2006, Krishnan 2003, Sommerkamp 1994, Grewal 2005).
Only one study to date has attempted to define the early effects of wrist mobilization following volar plate fixation of the distal radius (Lozano-Calderon 2008). That study prospectively enrolled 60 patients and randomized them to begin wrist motion at 2 weeks (range 7 days - 13 days) or 6 weeks (range 42 to 49 days) postoperatively. This study found no significant difference in subjective or objective outcome measures at 3 or 6 months follow up. However, the investigation had several weaknesses. First, there was no attempt to confirm adherence to the immobilization protocols. Those in the late motion group were not casted but remained in orthoplast splints which could be easily removed. Secondly, this investigation collected data only at 3 and 6 months which prohibited them from commenting on the rate of improvement during the early weeks after mobilization. The authors acknowledged these limitations and further noted that no evaluation of patient cost was performed. Finally, radiographic evaluations in this study did not include analysis of change in alignment from immediate postoperative films.
Thus, the literature to date suggests that early mobilization of the volarly plated distal radius is safe but does not improve final wrist motion. The benefits of mobilization in the early postoperative period though have not been clearly defined. This project proposes to fill this void in the literature and determine if early mobilization is an effective measure to hasten recovery of motion and function.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955734
|United States, Missouri|
|Washington University School of Medicine|
|St Louis, Missouri, United States, 63110|
|Principal Investigator:||Ryan Calfee, MD||Washington University School of Medicine|