Comparison of Two Methods for Treatment of Colles´s Fracture

University of Aarhus

Status: Completed

Conditions: Distal Radius Fracture; Colle´s Fracture

Treatments: Procedure: Osteosynthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT00609479

JOS-1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Experimental group

Description:

Internal fixation with Micronail. 41 patients.

Treatment:

Procedure: Osteosynthesis

2

Experimental group

Description:

External fixation with Hoffmann-II-non-bridging. 41 patients.

Treatment:

Procedure: Osteosynthesis