Early Motion After Volar Fixation for Distal Radius Fractures
|ClinicalTrials.gov Identifier: NCT00955734|
Recruitment Status : Completed
First Posted : August 10, 2009
Last Update Posted : June 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Radius Fracture||Other: Early motion Other: Immobilization||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Motion After Volar Fixation for Distal Radius Fractures: A Prospective Trial|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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.
- Wrist Motion [ Time Frame: 2 weeks - 1 year ]
- Patient Function [ Time Frame: 2 weeks - 1 year ]
- Patient Pain [ Time Frame: 2 weeks - 1 year ]
- Fracture reduction [ Time Frame: 2 week - 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|