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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00609479
Other study ID # JOS-1
Secondary ID JOS-1
Status Completed
Phase N/A
First received January 24, 2008
Last updated April 9, 2010
Start date January 2008
Est. completion date February 2010

Study information

Verified date April 2010
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Osteosynthesis
Micronail osteosynthesis. A cast for the first 14 days, thereafter starting physiotherapy. Control at weeks 1,2,5,12. Hoffmann-II-non-bridging osteosynthesis. Removal of device after 5 weeks. physiotherapy starts at 14 days. Control at weeks 1,2,5,12.

Locations

Country Name City State
Denmark Regionhospital Herning Herning
Denmark Regionhospital Holstebro Holstebro
Denmark Regionhospital Viborg Viborg

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary DASH-questionnaire 3 months No
Secondary PRWE-questionnaire 3 months No
See also
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