FractureNCT00314600
Treatment of Non-Dislocated Midshaft Both-Bone Fractures
A study testing above and below elbow cast in people with Fracture, run by Colaris, Joost, M.D. at 2 sites in Netherlands.
Trial summary
The investigators created a randomized clinical trial to find out what kind of treatment is optimal for non-dislocated both-bone midshaft forearm fractures. Read more about this study
- Who is it for?
- Ages Up to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture
- What is being tested?
- above and below elbow cast
- 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 midshaft forearm fracture
- Age < 16 years old
Who cannot join
- Dislocation
- Fracture older than 1 week
- No informed consent
- Refracture
- Open fracture (Gustillo 2 and 3)
- Torus fractures of both ulna and radius
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Erasmus Medical Centre, Sophia Children's Hospital
Rotterdam, South Holland, 3015GJ
Joost W Colaris, M.D., 0031-642220265, joostcolaris@hotmail.com
Joost W Colaris, M.D.
- Recruiting
HAGA, Juliana Children's Hospital
The Hague, South Holland, 2566ER
Joost W Colaris, M.D., 0031-642220265, joostcolaris@hotmail.com
Joost W Colaris, M.D.
About this study
Official title: Above Elbow Cast in Non-Dislocated Both-Bone Midshaft Forearm Fractures in Children: Necessity or Needless Cruelty? A Randomized Trial
The investigators created a randomized clinical trial to find out what kind of treatment is optimal for non-dislocated both-bone midshaft forearm fractures.
Read the detailed description
Children who arrive at the emergency unit with a non-dislocated both-bone midshaft forearm fracture will be asked to join the trial. After informed consent we will do a randomization between 6 weeks above elbow cast and 3 weeks above elbow cast in combination with 3 weeks under elbow cast.
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, complaints in daily living and complications.
- Conditions
- Fracture
- Being tested
- above and below elbow cast
- Keywords
- Fracture, Forearm, Midshaft, Child, Cast
- 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 and below elbow castDevice
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, complaints 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 posted14 Apr 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
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Colaris, Joost, M.D.
- Investigators
- Joost W Colaris, M.D., Principal investigator, HAGA/Erasmus Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314600
- Sponsor's protocol ID
- Colaris02
- Status last verified
- Nov 2006
- First submitted
- 12 Apr 2006
- Last updated
- 26 Feb 2007
- Results posted
- No
Publications
Colaris JW, Reijman M, Allema JH, Biter LU, Bloem RM, van de Ven CP, de Vries MR, Kerver AJ, Verhaar JA. Early conversion to below-elbow cast for non-reduced diaphyseal both-bone forearm fractures in children is safe: preliminary results of a multicentre randomised controlled trial. Arch Orthop Trauma Surg. 2013 Oct;133(10):1407-14. doi: 10.1007/s00402-013-1812-8. Epub 2013 Jul 17.
PubMed 23860674
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Above Elbow Cast in Non-Dislocated Both-Bone Midshaft Forearm Fractures in Children: Necessity or Needless Cruelty? A Randomized Trial
- ClinicalTrials.gov ID
- NCT00314600
- Acronym / sponsor ID
- Colaris02
- Conditions
- Fracture
- Keywords
- Fracture, Forearm, Midshaft, Child, Cast
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Colaris, Joost, M.D.
- Study start
- Jan 2006
- First posted
- 14 Apr 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.
The investigators created a randomized clinical trial to find out what kind of treatment is optimal for non-dislocated both-bone midshaft forearm fractures.
Detailed description
Children who arrive at the emergency unit with a non-dislocated both-bone midshaft forearm fracture will be asked to join the trial. After informed consent we will do a randomization between 6 weeks above elbow cast and 3 weeks above elbow cast in combination with 3 weeks under elbow cast.
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, complaints 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 (2 listed)
- Both-bone midshaft forearm fracture
- Age < 16 years old
Key exclusion criteria (6 listed)
- Dislocation
- 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 and below elbow cast | Device | – |
Primary outcome
pronation and supination
1 secondary outcome
complications, function, esthetics, complaints 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 26 Feb 2007.
- Derived from this study: PubMed 23860674Colaris JW, Reijman M, Allema JH, Biter LU, Bloem RM, van de Ven CP, de Vries MR, Kerver AJ, Verhaar JA. Early conversion to below-elbow cast for non-reduced diaphyseal both-bone forearm fractures in children is safe: preliminary results of a multicentre randomised controlled trial. Arch Orthop Trauma Surg. 2013 Oct;133(10):1407-14. doi: 10.1007/s00402-013-1812-8. Epub 2013 Jul 17.
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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, M.D. principal investigator
HAGA/Erasmus Medical Centre
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 and below elbow cast in people with Fracture, 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 2 inclusion and 6 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 26 Feb 2007. 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, M.D. (0031-642220265, 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 NCT00314600, 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 26 Feb 2007.