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

February 20, 2007
August 11, 2010
December 2004
Not Provided
range of motion in degrees of the wrists [ Time Frame: 6 months ] [ Designated as safety issue: No ]
range of motion in degrees of the wrists
Complete list of historical versions of study NCT00438308 on ClinicalTrials.gov Archive Site
  • 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 ]
  • DASH score
  • Likert pain scale
  • pinch and grip strength
  • Gartland and Werely score
  • and Mayo wrist score
Not Provided
Not Provided
 
Comparison of Early and Late Therapy for Adults With Operatively Treated Distal Radius Fractures
Prospective Randomized Comparison of Early and Late Wrist Mobilization After Volar Plate Fixation of a Fracture of the Distal Radius

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients from the MGH Hand and Upper Extremith Service

Distal Radius Fractures
Not Provided
  • 1
    Subjects who begin therapy immediately after fracture.
  • 2
    Subjects delay therapy for 3 weeks after injury.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2007
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00438308
2004-P-002118
Not Provided
David C Ring, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: David Ring, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP