- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00609479
Comparison of Two Methods for Treatment of Colles´s Fracture
April 9, 2010 updated by: University of Aarhus
Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.
The purpose of this study is to compare two different fixationmethods for fractures of the wrist(distal radius fractures).
We are comparing an external fixation (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail).
Primary endpoint is patient satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength, PRWE-questionnaire.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Herning, Denmark, 7400
- Regionhospital Herning
-
Holstebro, Denmark, 7500
- Regionhospital Holstebro
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Viborg, Denmark, 8800
- Regionhospital Viborg
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Fracture Older type 2.
- Fracture Older type 3.
Exclusion Criteria:
- Fractures older than 3 weeks.
- Pregnancy.
- Seq. after previous fracture.
- Distal fragments volar cortex < 10 mm.
- Open fracture larger than Gustillo 1.
- Disability due to other illness.
- Congenital abnormity or injury/disease in the affected extremity.
- Not capable of mentally/physically to cooperate.
- Not able to go to followup on the operating hospital.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Internal fixation with Micronail.
41 patients.
|
|
Experimental: 2
External fixation with Hoffmann-II-non-bridging. 41 patients.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
DASH-questionnaire
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PRWE-questionnaire
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kjeld Søballe, MD; PhD; Prof., Department of Orthopedics, University of Aarhus, Denmark
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
January 24, 2008
First Submitted That Met QC Criteria
February 6, 2008
First Posted (Estimate)
February 7, 2008
Study Record Updates
Last Update Posted (Estimate)
April 12, 2010
Last Update Submitted That Met QC Criteria
April 9, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JOS-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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