Comparison of Two Methods for Treatment of Colles´s Fracture
This study has been completed.
Sponsor:
University of Aarhus
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00609479
First received: January 24, 2008
Last updated: April 9, 2010
Last verified: April 2010
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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
|
|
Experimental: 2
External fixation with Hoffmann-II-non-bridging. 41 patients.
|
Procedure: Osteosynthesis
|
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 May 21, 2013