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

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438308
First received: February 20, 2007
Last updated: August 11, 2010
Last verified: August 2010
  Purpose

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.


Condition
Distal Radius Fractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Randomized Comparison of Early and Late Wrist Mobilization After Volar Plate Fixation of a Fracture of the Distal Radius

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • range of motion in degrees of the wrists [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DASH score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Likert pain scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • pinch and grip strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Gartland and Werely score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • and Mayo wrist score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2004
Study Completion Date: May 2007
Groups/Cohorts
1
Subjects who begin therapy immediately after fracture.
2
Subjects delay therapy for 3 weeks after injury.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from the MGH Hand and Upper Extremith Service

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00438308

Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David Ring, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: David C Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438308     History of Changes
Other Study ID Numbers: 2004-P-002118
Study First Received: February 20, 2007
Last Updated: August 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
distal radius fracture
rehabilitation
volar plate fixation
DASH questionnaire

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on August 26, 2014