Comparison of Two Methods for Treatment of Colles´s Fracture - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00609479

Purpose

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.

Condition	Intervention
Distal Radius Fracture Colle´s Fracture	Procedure: Osteosynthesis

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

DASH-questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PRWE-questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	82
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Internal fixation with Micronail. 41 patients.	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.
2: Experimental External fixation with Hoffmann-II-non-bridging. 41 patients.	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609479

Contacts

Contact: Jesper O. Schønnemann, MD	+4599125915	josc@ki.au.dk
Contact: Torben B. Hansen, MD; Phd	+4599125365	atbh@ringamt.dk

Locations

Denmark
Regionhospital Holstebro	Recruiting
Holstebro, Denmark, 7500
Principal Investigator: Jesper O. Schønnemann, MD
Regionhospital Herning	Recruiting
Herning, Denmark, 7400
Contact: Jesper O. Schønnemann, MD
Principal Investigator: Jesper O. Schønnemann, MD
Regionhospital Viborg	Recruiting
Viborg, Denmark, 8800
Contact: Jesper O. Schønnemann, MD
Principal Investigator: Jesper O. Schønnemann, MD

Sponsors and Collaborators

University of Aarhus

Investigators

Study Chair:

Kjeld Søballe, MD; PhD; Prof.

Department of Orthopedics, University of Aarhus, Denmark

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Orthopedic Research Unit, Regionhospital Holstebro ( MD/PhD-stud. Jesper Ougaard Schønnemann )
Study ID Numbers:	JOS-1, JOS-1
Study First Received:	January 24, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00609479
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:

Distal radius fracture
Colle´s fracture
Internal fixation

External fixation
DASH
PRWE

Study placed in the following topic categories:

Colles' Fracture
Fractures, Bone
Wounds and Injuries
Forearm Injuries

Disorders of Environmental Origin
Radius Fractures
Arm Injuries

ClinicalTrials.gov processed this record on January 16, 2009