Comparison of Two Methods for Treatment of Colles´s Fracture

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Colle´s Fracture Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regionhospital Herning, Herning, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osteosynthesis

Procedure

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.

Primary outcomes

DASH-questionnaire

Time frame: 3 months

Secondary outcomes

PRWE-questionnaire

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Feb 7, 2008
Registry last updated: Apr 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed