Wrist FracturesNCT00285961
Evaluation of Cork Splint Materials Instead of Plaster Splint for Children
A study testing Cork splint materials (instead of plaster splint) in people with Wrist Fractures and Forearm Fractures, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This is an evaluation of the functionality and added value of cork splint materials instead of a plaster splint for children (3-11 years old). Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Wrist Fractures, Forearm Fractures, Elbow Fractures
- What is being tested?
- Cork splint materials (instead of plaster splint)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Start not givento Apr 2004
- 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 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Fractures of the wrist, forearm, elbow, ankle, foot
- Distortions of the wrist, elbow, ankle
- Wounds without tendon injuries
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This is an evaluation of the functionality and added value of cork splint materials instead of a plaster splint for children (3-11 years old).
- Conditions
- Wrist Fractures, Forearm Fractures, Elbow Fractures, Ankle Fractures, Foot Fractures, Wounds and Injuries
- Being tested
- Cork splint materials (instead of plaster splint)
- Keywords
- Fractures of the wrist, forearm, elbow, ankle, foot, Distortions of the wrist, elbow, ankle, Wounds without tendon injuries
- Medical subject headings
- Wrist Fractures, Elbow Fractures, Ankle Fractures, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cork splint materials (instead of plaster splint)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality
Added value
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist FracturesStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Rene Verdonk, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285961
- Sponsor's protocol ID
- 2003/364
- Status last verified
- Feb 2009
- First submitted
- 1 Feb 2006
- Last updated
- 12 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cork Splint Materials Instead of Plaster Splint for Children
- ClinicalTrials.gov ID
- NCT00285961
- Acronym / sponsor ID
- 2003/364
- Conditions
- Wrist Fractures, Forearm Fractures, Elbow Fractures, Ankle Fractures, Foot Fractures, Wounds and Injuries
- Keywords
- Fractures of the wrist, forearm, elbow, ankle, foot, Distortions of the wrist, elbow, ankle, Wounds without tendon injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 2 Feb 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.
This is an evaluation of the functionality and added value of cork splint materials instead of a plaster splint for children (3-11 years old).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Fractures of the wrist, forearm, elbow, ankle, foot
- Distortions of the wrist, elbow, ankle
- Wounds without tendon injuries
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cork splint materials (instead of plaster splint) | Device | – |
Primary outcome
Functionality
Added value
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 12 May 2009.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Rene Verdonk, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cork splint materials (instead of plaster splint) in people with Wrist Fractures and Forearm Fractures, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 0 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 12 May 2009. 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 Belgium. 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?
Functionality. The study lists 2 primary outcomes in all. 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 12 May 2009.