Dorsal Splint or Circular Cast for Colles' Fracture?
Comparison of Dorsal Plaster Splint and Circular Plaster Cast for Colles' Fractures
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 7, 2007
CompletedFirst Posted
Study publicly available on registry
May 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedApril 8, 2015
April 1, 2015
3.6 years
May 7, 2007
April 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
redisplacement
dorsal angulation, radial tilt and radial shortening - radiographs
10 days
Secondary Outcomes (2)
pain
10 days
number of analgesic tablets
10 days
Study Arms (2)
complete plaster cast
EXPERIMENTALreduction and a complete plaster cast,
dorsal plaster splint
ACTIVE COMPARATORreduction and a dorsal plaster splint.
Interventions
Eligibility Criteria
You may qualify if:
- women 50 years and older
- Colles' fracture due to low energy trauma
You may not qualify if:
- high energy trauma
- age under 50 years
- dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Olavs Hospital
Trondheim, Norway
Related Publications (1)
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.
PMID: 19195651RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Vilh Finsen, MD, PhD
Dept of orthopaedic Surgery, St Olavs Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2007
First Posted
May 8, 2007
Study Start
June 1, 2004
Primary Completion
January 1, 2008
Study Completion
June 1, 2008
Last Updated
April 8, 2015
Record last verified: 2015-04