Early Motion After Volar Fixation for Distal Radius Fractures
Primary Purpose
Radius Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early motion
Immobilization
Sponsored by
About this trial
This is an interventional treatment trial for Radius Fracture focused on measuring wrist, fracture, motion, surgery
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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early motion
Immobilization
Arm Description
This group of patients will begin wrist motion 1 week after surgery.
This group will be casted for 6 weeks after surgery
Outcomes
Primary Outcome Measures
Wrist Motion
Secondary Outcome Measures
Patient Function
Patient Pain
Fracture reduction
Full Information
NCT ID
NCT00955734
First Posted
August 7, 2009
Last Updated
June 26, 2015
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00955734
Brief Title
Early Motion After Volar Fixation for Distal Radius Fractures
Official Title
Early Motion After Volar Fixation for Distal Radius Fractures: A Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fracture
Keywords
wrist, fracture, motion, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early motion
Arm Type
Experimental
Arm Description
This group of patients will begin wrist motion 1 week after surgery.
Arm Title
Immobilization
Arm Type
Active Comparator
Arm Description
This group will be casted for 6 weeks after surgery
Intervention Type
Other
Intervention Name(s)
Early motion
Intervention Description
One set of patients will begin wrist motion at 1 week after surgery.
Intervention Type
Other
Intervention Name(s)
Immobilization
Intervention Description
This set of patients will be casted for 6 weeks after surgery.
Primary Outcome Measure Information:
Title
Wrist Motion
Time Frame
2 weeks - 1 year
Secondary Outcome Measure Information:
Title
Patient Function
Time Frame
2 weeks - 1 year
Title
Patient Pain
Time Frame
2 weeks - 1 year
Title
Fracture reduction
Time Frame
2 week - 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Calfee, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Motion After Volar Fixation for Distal Radius Fractures
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