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Sponsored by: |
University of Aarhus |
Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00609479 |
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.
Condition | Intervention |
Distal Radius Fracture Colle´s Fracture |
Procedure: Osteosynthesis |
MedlinePlus related topics: | Fractures |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study. |
Estimated Enrollment: | 82 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Internal fixation with Micronail. 41 patients.
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Procedure: Osteosynthesis
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2: Experimental
External fixation with Hoffmann-II-non-bridging. 41 patients.
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Procedure: Osteosynthesis
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jesper O. Schønnemann, MD | +4599125915 | josc@ki.au.dk |
Contact: Torben B. Hansen, MD; Phd | +4599125365 | atbh@ringamt.dk |
Denmark | |||||
Regionhospital Holstebro | Recruiting | ||||
Holstebro, Denmark, 7500 | |||||
Principal Investigator: Jesper O. Schønnemann, MD | |||||
Regionhospital Herning | Recruiting | ||||
Herning, Denmark, 7400 | |||||
Contact: Jesper O. Schønnemann, MD | |||||
Principal Investigator: Jesper O. Schønnemann, MD | |||||
Regionhospital Viborg | Recruiting | ||||
Viborg, Denmark, 8800 | |||||
Contact: Jesper O. Schønnemann, MD | |||||
Principal Investigator: Jesper O. Schønnemann, MD |
University of Aarhus |
Study Chair: | Kjeld Søballe, MD; PhD; Prof. | Department of Orthopedics, University of Aarhus, Denmark |
Related Info 
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Responsible Party: | Orthopedic Research Unit, Regionhospital Holstebro ( MD/PhD-stud. Jesper Ougaard Schønnemann ) |
Study ID Numbers: | JOS-1, JOS-1 |
First Received: | January 24, 2008 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00609479 |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
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