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Comparison of Two Methods for Treatment of Colles´s Fracture

Primary Purpose

Distal Radius Fracture, Colle´s Fracture

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Osteosynthesis
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal radius fracture, Colle´s fracture, Internal fixation, External fixation, DASH, PRWE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Regionhospital Herning
  • Regionhospital Holstebro
  • Regionhospital Viborg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Internal fixation with Micronail. 41 patients.

External fixation with Hoffmann-II-non-bridging. 41 patients.

Outcomes

Primary Outcome Measures

DASH-questionnaire

Secondary Outcome Measures

PRWE-questionnaire

Full Information

First Posted
January 24, 2008
Last Updated
April 9, 2010
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00609479
Brief Title
Comparison of Two Methods for Treatment of Colles´s Fracture
Official Title
Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Colle´s Fracture
Keywords
Distal radius fracture, Colle´s fracture, Internal fixation, External fixation, DASH, PRWE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Internal fixation with Micronail. 41 patients.
Arm Title
2
Arm Type
Experimental
Arm Description
External fixation with Hoffmann-II-non-bridging. 41 patients.
Intervention Type
Procedure
Intervention Name(s)
Osteosynthesis
Intervention Description
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 Outcome Measure Information:
Title
DASH-questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
PRWE-questionnaire
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Søballe, MD; PhD; Prof.
Organizational Affiliation
Department of Orthopedics, University of Aarhus, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Regionhospital Herning
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Regionhospital Holstebro
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Facility Name
Regionhospital Viborg
City
Viborg
ZIP/Postal Code
8800
Country
Denmark

12. IPD Sharing Statement

Links:
URL
http://www.orthoresearch.dk
Description
Related Info

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Comparison of Two Methods for Treatment of Colles´s Fracture

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