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Clinical Trials/NCT00438308
NCT00438308
Completed
N/A

Prospective Randomized Comparison of Early and Late Wrist Mobilization After Volar Plate Fixation of a Fracture of the Distal Radius

Massachusetts General Hospital0 sites60 target enrollmentDecember 2004

Overview

Phase
N/A
Intervention
Not specified
Conditions
Distal Radius Fractures
Sponsor
Massachusetts General Hospital
Enrollment
60
Primary Endpoint
range of motion in degrees of the wrists
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2004
End Date
May 2007
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

range of motion in degrees of the wrists

Time Frame: 6 months

Secondary Outcomes

  • 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)

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