Comparison of Early and Late Therapy for Adults With Operatively Treated Distal Radius Fractures

Completed

• Conditions: Distal Radius Fractures

• Registration Number: NCT00438308
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of the study is to compare two common ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

Detailed Description

Over the last three decades, operative treatment of distal radius fractures has become increasingly common compared to non-operative treatment. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that, similar to other periarticular fractures, it would be beneficial to allow early movement of the wrist articulation. There is not, however, any data to support this statement. In fact, data regarding external fixation that either immobilizes the wrist or allows wrist motion suggest that early wrist mobilization is not as important as the overall alignment of the bone in terms of final wrist motion. This question is important in patient care and in decision-making regarding these fractures. Additionally, many companies use this claim as a marketing point in spite of the lack of evidence. We consider that good quality data is needed to determine the answer to this issue and to help to resolve the related problems described above.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-21
• Study First Posted: 2007-02-22
• Study Completion: 2007-05
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-11
• Last Update Posted: 2010-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Gender: Male or female
• Age: Older than 18
• Isolated distal radial fracture
• Fracture treated with volar plates, stable fixation
• Initial treatment within 4 weeks of trauma

Exclusion Criteria

• Complex fractures that require additional or different material than volar plates
• Unstable fractures in which early mobilization is contraindicated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
range of motion in degrees of the wrists	6 months

Secondary Outcome Measures

Name	Time	Method
DASH score	6 months
Likert pain scale	6 months
pinch and grip strength	6 months
Gartland and Werely score	6 months
and Mayo wrist score	6 months