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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00989222 |
Date of registration:
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02/10/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?
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Scientific title:
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Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? A Prospective Randomized Study |
Date of first enrolment:
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January 2006 |
Target sample size:
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63 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00989222 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, 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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Contacts
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Name:
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Gustaf Neander, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of
more than 20 degrees or radial shortening of 4 mm or more, AND
- Patient aged 20-70 years with no previous fracture of either wrist.
Exclusion Criteria:
- Bilateral fractures,
- Other current injury to the upper extremities,
- Dementia, OR
- Severe comminution or too small distal fragment to allow plating.
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Radius Fractures
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Intervention(s)
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Procedure: closed reduction and external fixation
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Procedure: Internal fixation with a volar locked plate
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Primary Outcome(s)
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PRWE (patient rated wrist evaluation) score
[Time Frame: 3,6 and 12 months]
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Secondary Outcome(s)
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Objective function (range of movement and grip strength)
[Time Frame: 3,6 and 12 months]
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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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