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Clinical Trials/NCT00955734
NCT00955734
Completed
Not Applicable

Early Motion After Volar Fixation for Distal Radius Fractures: A Prospective Trial

Washington University School of Medicine1 site in 1 country25 target enrollmentJune 2009
ConditionsRadius Fracture

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radius Fracture
Sponsor
Washington University School of Medicine
Enrollment
25
Locations
1
Primary Endpoint
Wrist Motion
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ryan Calfee, MD

Associate Professor of Orthopaedic Surgery

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Adults over 18 years of age having volar internal fixation for distal radius fractures.

Exclusion Criteria

  • Patients will be excluded if immobilization is required for distal radioulnar joint instability (whether operatively pinned or simply immobilized in supination) or an associated carpal injury.
  • Patients with concurrent fracture of the ulna proximal to the base of the ulnar styloid will be excluded.

Outcomes

Primary Outcomes

Wrist Motion

Time Frame: 2 weeks - 1 year

Secondary Outcomes

  • Patient Function(2 weeks - 1 year)
  • Patient Pain(2 weeks - 1 year)
  • Fracture reduction(2 week - 1 year)

Study Sites (1)

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