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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01035359 |
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Date of registration:
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16/12/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intraarticular Distal Radius Fractures, X-fix or Volar Fixation
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Scientific title:
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Dorsally Displaced Intraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial. |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01035359 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female 50-74 years or male 60-74 years
- Dorsally displaced intraarticular distal radius fracture
- Dorsal angulation >20 degrees measured from the plane perpendicular to the radius
axis
- Low energy trauma
- Injury <72 hours when diagnosed
- Patient independent of help for ADL
Exclusion Criteria:
- Earlier dysfunction in any wrist
- Other major injuries
- Rheumatoid arthritis or other systemic joint disease
- Dementia or severe psychiatric disease
- Severe medical condition making general anesthesia a major risk
Age minimum:
50 Years
Age maximum:
74 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Low Energy Trauma
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Dorsally Displaced Intraarticular Distal Radius Fractures
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Age 50 - 74 for Females or 60-74 for Males
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Intervention(s)
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Procedure: External fixation
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Procedure: Volar plate
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Primary Outcome(s)
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The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb.
[Time Frame: 12 months]
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Secondary Outcome(s)
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A secondary outcome is the degree of malalignment on the x-ray of the injured wrist.
[Time Frame: 12 months]
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A secondary outcome of this study is the EQ5D, which is a validated quality-of-life instrument.
[Time Frame: 12 months]
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Secondary ID(s)
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DRF intra
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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