Early Motion After Volar Fixation for Distal Radius Fractures

NCT ID: NCT00955734

Last Updated: 2015-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2015-06-30

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.

Conditions

Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early motion

This group of patients will begin wrist motion 1 week after surgery.

Group Type: EXPERIMENTAL

Early motion

Intervention Type: OTHER

One set of patients will begin wrist motion at 1 week after surgery.

Immobilization

This group will be casted for 6 weeks after surgery

Group Type: ACTIVE_COMPARATOR

Immobilization

Intervention Type: OTHER

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

Interventions

Early motion

One set of patients will begin wrist motion at 1 week after surgery.

Intervention Type: OTHER

Immobilization

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ryan Calfee, MD

Associate Professor of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Calfee, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

09-0566

Identifier Type: -

Identifier Source: org_study_id