FractureNCT00397995
Undislocated Distal Both-Bone Forearm Fractures in Children
A study testing above- or under elbow cast in people with Fracture and Forearm, run by Colaris, Joost, M.D. at 2 sites in Netherlands.
Trial summary
We create a randomized clinical trial between above- and below elbow cast to find out what kind of treatment is optimal for undislocated both-bone distal forearm fractures. Read more about this study
- Who is it for?
- Ages Up to 15 yearsHealthy volunteers can take part
- What is being tested?
- above- or under elbow cast
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2006to not given
- 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 Up to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- both-bone forearm fracture
- distal
- undislocated
- age < 16 years
Who cannot join
- fracture older than 1 week
- no informed consent
- refracture
- open fracture (Gustillo 2 and 3)
- both fractures type torus
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Erasmus Medical Centre location Sophia Children's hospital
Rotterdam, South Holland
joost w colaris, drs, 0031642220265, joostcolaris@hotmail.com
- Recruiting
HAGA, location Juliana Children's Hospital
The Hague, South Holland
joost w colaris, 0031642220265, joostcolaris@hotmail.com
About this study
Official title: Treatment of Undislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With Above- and Under Elbow Cast.
We create a randomized clinical trial between above- and below elbow cast to find out what kind of treatment is optimal for undislocated both-bone distal forearm fractures.
Read the detailed description
children who arrive at the emergency unit with a undislocated both-bone distal forearm fracture will be asked to join the trial.
After informed consent, a randomization between 2 kinds of cast will be done.
Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.
- Being tested
- above- or under elbow cast
- Keywords
- Fracture, Forearm, Distal, Child, Treatment
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
above- or under elbow castProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pronation and supination
Secondary outcomes (1)
complications, function, esthetics, complains in daily living, X-rays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Colaris, Joost, M.D.
- Investigators
- joost w Colaris, drs, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397995
- Sponsor's protocol ID
- Colaris04
- Status last verified
- Nov 2006
- First submitted
- 8 Nov 2006
- Last updated
- 10 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Undislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With Above- and Under Elbow Cast.
- ClinicalTrials.gov ID
- NCT00397995
- Acronym / sponsor ID
- Colaris04
- Keywords
- Fracture, Forearm, Distal, Child, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Colaris, Joost, M.D.
- Study start
- Jan 2006
- First posted
- 10 Nov 2006 (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.
We create a randomized clinical trial between above- and below elbow cast to find out what kind of treatment is optimal for undislocated both-bone distal forearm fractures.
Detailed description
children who arrive at the emergency unit with a undislocated both-bone distal forearm fracture will be asked to join the trial.
After informed consent, a randomization between 2 kinds of cast will be done.
Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- both-bone forearm fracture
- distal
- undislocated
- age < 16 years
Key exclusion criteria (5 listed)
- fracture older than 1 week
- no informed consent
- refracture
- open fracture (Gustillo 2 and 3)
- both fractures type torus
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 |
|---|---|---|
| above- or under elbow cast | Procedure or surgery | – |
Primary outcome
pronation and supination
1 secondary outcome
complications, function, esthetics, complains in daily living, X-rays
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2006.
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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.
joost w Colaris, drs principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing above- or under elbow cast in people with Fracture and Forearm, run by Colaris, Joost, M.D. at 2 sites in Netherlands.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact joost w colaris, drs (0031642220265, joostcolaris@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pronation and supination. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2006.