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
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
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on April 17, 2014