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Comparison of Two Methods for Treatment of Colles´s Fracture

Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00609479
Enrollment
60
Registered
2008-02-07
Start date
2008-01-31
Completion date
2010-02-28
Last updated
2010-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colle´s Fracture, Distal Radius Fracture

Keywords

Distal radius fracture, Colle´s fracture, Internal fixation, External fixation, DASH, PRWE

Brief 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.

Interventions

PROCEDUREOsteosynthesis

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

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
DASH-questionnaire3 months

Secondary

MeasureTime frame
PRWE-questionnaire3 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026