Colles' FractureNCT00470691
Dorsal Splint or Circular Cast for Colles' Fracture?
A study testing plaster cast and dorsal splint in people with Colles' Fracture, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Colles' Fracture
- What is being tested?
- plaster cast and dorsal splint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2004to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women 50 years and older
- Colles' fracture due to low energy trauma
Who cannot join
- high energy trauma
- age under 50 years
- dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Dorsal Plaster Splint and Circular Plaster Cast for Colles' Fractures
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.
- Conditions
- Colles' Fracture
- Being tested
- plaster cast, dorsal splint
- Medical subject headings
- Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plaster castProcedure or surgery
complete circular plaster cast
dorsal splintProcedure or surgery
dorsal plaster splint
| Study group | Role | What they receive |
|---|---|---|
| complete plaster cast | Experimental | reduction and a complete plaster cast, Receives: Procedure: plaster cast |
| dorsal plaster splint | Active comparator | reduction and a dorsal plaster splint. Receives: Procedure: dorsal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
redisplacement
dorsal angulation, radial tilt and radial shortening - radiographs
Measured: 10 days
Secondary outcomes (2)
pain
pain during past 24h on a VAS
Measured: 10 days
number of analgesic tablets
number of analgesic tablets taken during the 10 days after reduction.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2007 (estimated)
- Study startJun 2004
- Primary completionJan 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colles' FractureStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vilh Finsen, MD, PhD, Study chair, Dept of orthopaedic Surgery, St Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470691
- Sponsor's protocol ID
- StOlavsH-ort-radius
- Status last verified
- Apr 2015
- First submitted
- 7 May 2007
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.injury.2008.08.044. Epub 2009 Feb 4.
PubMed 19195651
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dorsal Plaster Splint and Circular Plaster Cast for Colles' Fractures
- ClinicalTrials.gov ID
- NCT00470691
- Acronym / sponsor ID
- StOlavsH-ort-radius
- Conditions
- Colles' Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 8 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete plaster cast | Experimental | Procedure: plaster castreduction and a complete plaster cast, |
| dorsal plaster splint | Active comparator | Procedure: dorsal splintreduction and a dorsal plaster splint. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women 50 years and older
- Colles' fracture due to low energy trauma
Key exclusion criteria (3 listed)
- high energy trauma
- age under 50 years
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plaster castcomplete circular plaster cast | Procedure or surgery | complete plaster cast |
| dorsal splintdorsal plaster splint | Procedure or surgery | dorsal plaster splint |
Primary outcome
redisplacement
Time frame: 10 days
dorsal angulation, radial tilt and radial shortening - radiographs
2 secondary outcomes
pain
Time frame: 10 days
number of analgesic tablets
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Results publication: PubMed 19195651Wik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilh Finsen, MD, PhD study chair
Dept of orthopaedic Surgery, St Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plaster cast and dorsal splint in people with Colles' Fracture, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
redisplacement (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00470691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.