Back to resultsDorsal Splint or Circular Cast for Colles' Fracture?
Primary Purpose
Colles' Fracture
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
plaster cast
dorsal splint
Sponsored by
About this trial
This is an interventional treatment trial for Colles' Fracture
Eligibility Criteria
Inclusion Criteria:
- women 50 years and older
- Colles' fracture due to low energy trauma
Exclusion Criteria:
- high energy trauma
- age under 50 years
- dementia
Sites / Locations
- St. Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
complete plaster cast
dorsal plaster splint
Arm Description
reduction and a complete plaster cast,
reduction and a dorsal plaster splint.
Outcomes
Primary Outcome Measures
redisplacement
dorsal angulation, radial tilt and radial shortening - radiographs
Secondary Outcome Measures
pain
pain during past 24h on a VAS
number of analgesic tablets
number of analgesic tablets taken during the 10 days after reduction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00470691
Brief Title
Dorsal Splint or Circular Cast for Colles' Fracture?
Official Title
Comparison of Dorsal Plaster Splint and Circular Plaster Cast for Colles' Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colles' Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
complete plaster cast
Arm Type
Experimental
Arm Description
reduction and a complete plaster cast,
Arm Title
dorsal plaster splint
Arm Type
Active Comparator
Arm Description
reduction and a dorsal plaster splint.
Intervention Type
Procedure
Intervention Name(s)
plaster cast
Intervention Description
complete circular plaster cast
Intervention Type
Procedure
Intervention Name(s)
dorsal splint
Intervention Description
dorsal plaster splint
Primary Outcome Measure Information:
Title
redisplacement
Description
dorsal angulation, radial tilt and radial shortening - radiographs
Time Frame
10 days
Secondary Outcome Measure Information:
Title
pain
Description
pain during past 24h on a VAS
Time Frame
10 days
Title
number of analgesic tablets
Description
number of analgesic tablets taken during the 10 days after reduction.
Time Frame
10 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women 50 years and older
Colles' fracture due to low energy trauma
Exclusion Criteria:
high energy trauma
age under 50 years
dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilh Finsen, MD, PhD
Organizational Affiliation
Dept of orthopaedic Surgery, St Olavs Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
19195651
Citation
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. doi: 10.1016/j.injury.2008.08.044. Epub 2009 Feb 4.
Results Reference
result
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Dorsal Splint or Circular Cast for Colles' Fracture?
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