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Clinical Trials/NCT00438750
NCT00438750
Completed
N/A

Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius

Massachusetts General Hospital1 site in 1 country94 target enrollmentJanuary 2007

Overview

Phase
N/A
Intervention
Not specified
Conditions
Distal Radius Fractures
Sponsor
Massachusetts General Hospital
Enrollment
94
Locations
1
Primary Endpoint
Range of Motion in Degrees of the Wrists
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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

Detailed Description

Operative treatment of distal radius fractures has become commonplace over the last three decades as our understanding of the relationship between the alignment of the distal radius and the function of the wrist and forearm has improved. 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 it would be beneficial to allow early movement of the wrist articulation in an attempt to maximize final outcome. There is a difference in opinion among physicians on the importance of supervision of exercises in the recovery process. Some physicians advocate formal occupational therapy while other physicians believe that appropriate instructions for home exercises are just as good. A common belief is that the motivation of the patient plays an important part in recovery. In addition, Psychological and personality factors, such as pain anxiety, catastrophizing, and depression are strongly related to upper extremity specific health status and may also influence recovery. The goal of this study is to determine which protocol for exercises leads to better outcome in patients treated for distal radius with a volar plate. As a secondary goal and to generate hypotheses for later studies we would like to evaluate the influence of psychosocial factors on both objective (motion, grip strength) and subjective (DASH questionnaire) measures of functional recovery.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
May 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David C. Ring, MD

Principal Investigator; Director of Research, Hand Service

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age 18 or greater.
  • 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.

Outcomes

Primary Outcomes

Range of Motion in Degrees of the Wrists

Time Frame: 6 months

Mean arc of wrist flexion and extension six months after surgery. Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees.

Secondary Outcomes

  • Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire(6 months)
  • 10-point Ordinal Pain Scale(6 months)
  • Pinch Strength(6 months)
  • Gartland and Werley Score(6 months)
  • Mayo Wrist Score(6 months)
  • Grip Strength(6 months)

Study Sites (1)

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