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

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ClinicalTrials.gov Identifier: NCT00438308
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : August 12, 2010
Sponsor:
Information provided by:
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.

Condition or disease
Distal Radius Fractures

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 Type : Observational
Actual Enrollment : 60 participants
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
Study Start Date : December 2004
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Subjects who begin therapy immediately after fracture.
2
Subjects delay therapy for 3 weeks after injury.



Primary Outcome Measures :
  1. range of motion in degrees of the wrists [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. DASH score [ Time Frame: 6 months ]
  2. Likert pain scale [ Time Frame: 6 months ]
  3. pinch and grip strength [ Time Frame: 6 months ]
  4. Gartland and Werely score [ Time Frame: 6 months ]
  5. and Mayo wrist score [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438308


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

Responsible Party: David C Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438308     History of Changes
Other Study ID Numbers: 2004-P-002118
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: August 12, 2010
Last Verified: August 2010

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