Early Motion After Volar Fixation for Distal Radius Fractures

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00955734

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Radius Fracture	Other: Early motion Other: Immobilization	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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	Other: Immobilization This set of patients will be casted for 6 weeks after surgery.

Arm

Intervention/Treatment

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

Other: Immobilization

This set of patients will be casted for 6 weeks after surgery.

Outcome Measures

Primary Outcome Measures

Wrist Motion [2 weeks - 1 year]

Secondary Outcome Measures

Patient Function [2 weeks - 1 year]
Patient Pain [2 weeks - 1 year]
Fracture reduction [2 week - 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.