Distal Radius Fracture Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Regionhospital Herning | Herning | |
Denmark | Regionhospital Holstebro | Holstebro | |
Denmark | Regionhospital Viborg | Viborg |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DASH-questionnaire | 3 months | No | |
Secondary | PRWE-questionnaire | 3 months | No |
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---|---|---|---|
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