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Comparison of Two Methods for Treatment of Colles´s Fracture

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00609479
First received: January 24, 2008
Last updated: April 9, 2010
Last verified: April 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.

Resource links provided by NLM:


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: 60
Study Start Date: January 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Internal fixation with Micronail. 41 patients.
Procedure: Osteosynthesis
  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.
Experimental: 2
External fixation with Hoffmann-II-non-bridging. 41 patients.
Procedure: Osteosynthesis
  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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Regionhospital Herning
Herning, Denmark, 7400
Regionhospital Holstebro
Holstebro, Denmark, 7500
Regionhospital Viborg
Viborg, Denmark, 8800
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Kjeld Søballe, MD; PhD; Prof. Department of Orthopedics, University of Aarhus, Denmark
  More Information

Additional Information:
No publications provided

Responsible Party: MD/PhD-stud. Jesper Ougaard Schønnemann, Orthopedic Research Unit, Regionhospital Holstebro
ClinicalTrials.gov Identifier: NCT00609479     History of Changes
Other Study ID Numbers: JOS-1, JOS-1
Study First Received: January 24, 2008
Last Updated: April 9, 2010
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

Additional relevant MeSH terms:
Colles' Fracture
Fractures, Bone
Radius Fractures
Arm Injuries
Forearm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014