Early Motion After Volar Fixation for Distal Radius Fractures

Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955734
• Other study ID #: 09-0566
• Status: Completed
• Phase: N/A
• First received: August 7, 2009
• Last updated: June 26, 2015
• Start date: June 2009
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fracture
• Radius Fractures

Intervention

Other:
• Early motion
One set of patients will begin wrist motion at 1 week after surgery.
• Immobilization
This set of patients will be casted for 6 weeks after surgery.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wrist Motion		2 weeks - 1 year	No
Secondary	Patient Function		2 weeks - 1 year	No
Secondary	Patient Pain		2 weeks - 1 year	No
Secondary	Fracture reduction		2 week - 1 year	Yes