Dorsal Splint or Circular Cast for Colles' Fracture?
This study has been completed.
Sponsor:
St. Olavs Hospital
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00470691
First received: May 7, 2007
Last updated: October 20, 2011
Last verified: October 2011
| Tracking Information | |||||
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| First Received Date ICMJE | May 7, 2007 | ||||
| Last Updated Date | October 20, 2011 | ||||
| Start Date ICMJE | June 2004 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
redisplacement [ Time Frame: 10 days ] [ Designated as safety issue: No ] dorsal angulation, radial tilt and radial shortening - radiographs |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00470691 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dorsal Splint or Circular Cast for Colles' Fracture? | ||||
| Official Title ICMJE | Comparison of Dorsal Plaster Splint and Circular Plaster Cast for Colles' Fractures | ||||
| Brief Summary | At our hospital, all Colles' fractures deemed suitable for conservative treatment are reduced and immobilised with a plaster of Paris dorsal splint which is converted to a complete cast after 10 days. According to individual factors such as age, general health and radiological results after 10 days, some patients with severe redisplacement are readmitted to hospital for surgery. The main purpose of this study is to determine whether, during the first 10 days of immobilisation, a complete plaster cast or a dorsal plaster splint best retains the alignment of a reduced Colles' fracture. In addition, we aim to compare the complication rates of the two methods. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Colles' Fracture | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Wik TS, Aurstad AT, Finsen V. Colles' fracture: dorsal splint or complete cast during the first 10 days? Injury. 2009 Apr;40(4):400-4. Epub 2009 Feb 4. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 72 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00470691 | ||||
| Other Study ID Numbers ICMJE | StOlavsH-ort-radius | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | St. Olavs Hospital | ||||
| Study Sponsor ICMJE | St. Olavs Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | St. Olavs Hospital | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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