FractureNCT00398242
Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children
A study testing above or below elbow cast for the last 3 weeks of treatment 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 the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone 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 below elbow cast for the last 3 weeks of treatment
- Type of treatment
- Medical device
- 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
- age < 16 years
- dislocation
- stable
Who cannot join
- fracture older than 1 week
- no informed consent
- refracture
- open fracture (Gustillo 2 and 3)
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
- Recruiting
HAGA, location Juliana Children's Hospital
The Hague, South Holland
Joost W Colaris, Drs, 00316-42220265, joostcolaris@hotmail.com
About this study
Official title: Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between Treatment With Above Elbow Cast and a Combination of Above- and Below Elbow Armcast.
We create a randomized clinical trial between the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone forearm fractures.
Read the detailed description
children who arrive at the emergency unit with a stable both-bone midshaft forearm fracture will be asked to join the trial.
If the fracture will be stable during reposition in the operating room, a randomization between 2 kinds of plaster treatment 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 below elbow cast for the last 3 weeks of treatment
- Keywords
- fracture, forearm, midshaft, 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 below elbow cast for the last 3 weeks of treatmentDevice
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- 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
- NCT00398242
- Sponsor's protocol ID
- Colaris03
- Status last verified
- Nov 2006
- First submitted
- 8 Nov 2006
- Last updated
- 10 Nov 2006
- Results posted
- No
Publications
Musters L, Roth KC, Diederix LW, Edomskis PP, Benner JL, Reijman M, Eygendaal D, Colaris JW. Does Early Conversion to Below-elbow Casting for Pediatric Diaphyseal Both-bone Forearm Fractures Adversely Affect Patient-reported Outcomes and ROM? Clin Orthop Relat Res. 2024 Oct 1;482(10):1873-1881. doi: 10.1097/CORR.0000000000003100. Epub 2024 May 7.
PubMed 38813962
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 Stable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between Treatment With Above Elbow Cast and a Combination of Above- and Below Elbow Armcast.
- ClinicalTrials.gov ID
- NCT00398242
- Acronym / sponsor ID
- Colaris03
- Keywords
- fracture, forearm, midshaft, 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 the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone forearm fractures.
Detailed description
children who arrive at the emergency unit with a stable both-bone midshaft forearm fracture will be asked to join the trial.
If the fracture will be stable during reposition in the operating room, a randomization between 2 kinds of plaster treatment 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
- Single blind
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
- age < 16 years
- dislocation
- stable
Key exclusion criteria (4 listed)
- fracture older than 1 week
- no informed consent
- refracture
- open fracture (Gustillo 2 and 3)
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 below elbow cast for the last 3 weeks of treatment | Device | – |
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.
- Derived from this study: PubMed 38813962Musters L, Roth KC, Diederix LW, Edomskis PP, Benner JL, Reijman M, Eygendaal D, Colaris JW. Does Early Conversion to Below-elbow Casting for Pediatric Diaphyseal Both-bone Forearm Fractures Adversely Affect Patient-reported Outcomes and ROM? Clin Orthop Relat Res. 2024 Oct 1;482(10):1873-1881. doi: 10.1097/CORR.0000000000003100. Epub 2024 May 7.
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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 below elbow cast for the last 3 weeks of treatment 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 4 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 (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?
On the ClinicalTrials.gov record for NCT00398242, 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 10 Nov 2006.