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Comparison of Two Methods for Treatment of Colles´s Fracture

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ClinicalTrials.gov Identifier: NCT00609479
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : April 12, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Distal Radius Fracture Colle´s Fracture Procedure: Osteosynthesis

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.
Study Start Date : January 2008
Primary Completion Date : February 2010
Study Completion Date : February 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. DASH-questionnaire [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. PRWE-questionnaire [ Time Frame: 3 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: April 12, 2010
Last Verified: April 2010

Keywords provided by University of Aarhus:
Distal radius fracture
Colle´s fracture
Internal fixation
External fixation
DASH
PRWE

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Colles' Fracture
Wounds and Injuries
Forearm Injuries
Arm Injuries
Fracture Dislocation
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases