Scaphoid BonePhase 1NCT00292006
Computerized Tomography to Help Diagnosis Pediatrics Scaphoid Fractures.
A Phase 1 study testing Computerized tomography in people with Scaphoid Bone and Fracture, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to find out whether computerized tomography will be better than plain radiographs in determining pediatrics scaphoid fractures. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scaphoid Bone, Fracture
- What is being tested?
- Computerized tomography
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento Jun 2007
- Phase
- Phase 1
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pain in anatomical snuffbox, Negative radiographs, less than 18 years old, older than 6 years old, injury less than 1 week old and provision of informed consent
Who cannot join
- Previous injury to scaphoid bone, other injuries on the same extremity, vascular injury present at the injury site, fracture seen on initial radiographs, injury >1 week old, inability for patient to comply with rehabilitation or form completion, likely problems in maintaining patient follow-up
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Center Victoria Hospital
London, Ontario, N6A 5W9
About this study
Official title: The Efficiency of Computerized Tomography to Aid in the Diagnosis of Pediatrics Scaphoid Fractures
The purpose of this study is to find out whether computerized tomography will be better than plain radiographs in determining pediatrics scaphoid fractures.
Read the detailed description
Background: The use of plain radiograph in the detection of pediatrics scaphoid fractures has low specificity and sensitivity. Patients with documented anatomical snuffbox tenderness and negative plain radiographs are casted in thumb spica casts and seen by a pediatrics orthopedics surgeon. However few patients with clinical scaphoid fractures have documented scaphoid fractures, with the most common injury of soft tissue injury to the surrounding tissues. The use of CT scan to detect scaphoid fractures is not well documented and may be an appropriate substitute for plain radiographs.
Hypothesis: CT scan of the wrist will have higher sensitivity and specificity in detecting pediatrics scaphoid fracture than plain radiographs.
- Conditions
- Scaphoid Bone, Fracture
- Being tested
- Computerized tomography
- Keywords
- clinical scaphoid fracture, pediatric
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized tomographyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Scaphoid BoneStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Investigators
- Tim P Carey, MD, FRCSC, Study chair, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292006
- Sponsor's protocol ID
- 11955
- Status last verified
- Feb 2006
- First submitted
- 14 Feb 2006
- Last updated
- 23 Aug 2017
- Results posted
- No
Publications
Temple CL, Ross DC, Bennett JD, Garvin GJ, King GJ, Faber KJ. Comparison of sagittal computed tomography and plain film radiography in a scaphoid fracture model. J Hand Surg Am. 2005 May;30(3):534-42. doi: 10.1016/j.jhsa.2005.01.001.
PubMed 15925164Breederveld RS, Tuinebreijer WE. Investigation of computed tomographic scan concurrent criterion validity in doubtful scaphoid fracture of the wrist. J Trauma. 2004 Oct;57(4):851-4. doi: 10.1097/01.ta.0000124278.29127.42.
PubMed 15514541
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Computerized Tomography to Aid in the Diagnosis of Pediatrics Scaphoid Fractures
- ClinicalTrials.gov ID
- NCT00292006
- Acronym / sponsor ID
- 11955
- Conditions
- Scaphoid Bone, Fracture
- Keywords
- clinical scaphoid fracture, pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study completion
- Jun 2007
- First posted
- 15 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.
The purpose of this study is to find out whether computerized tomography will be better than plain radiographs in determining pediatrics scaphoid fractures.
Detailed description
Background: The use of plain radiograph in the detection of pediatrics scaphoid fractures has low specificity and sensitivity. Patients with documented anatomical snuffbox tenderness and negative plain radiographs are casted in thumb spica casts and seen by a pediatrics orthopedics surgeon. However few patients with clinical scaphoid fractures have documented scaphoid fractures, with the most common injury of soft tissue injury to the surrounding tissues. The use of CT scan to detect scaphoid fractures is not well documented and may be an appropriate substitute for plain radiographs.
Hypothesis: CT scan of the wrist will have higher sensitivity and specificity in detecting pediatrics scaphoid fracture than plain radiographs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pain in anatomical snuffbox, Negative radiographs, less than 18 years old, older than 6 years old, injury less than 1 week old and provision of informed consent
Key exclusion criteria (1 listed)
- Previous injury to scaphoid bone, other injuries on the same extremity, vascular injury present at the injury site, fracture seen on initial radiographs, injury >1 week old, inability for patient to comply with rehabilitation or form completion, likely problems in maintaining patient follow-up
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 |
|---|---|---|
| Computerized tomography | Device | – |
Primary outcome
Fracture diagnosis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Background: PubMed 15925164Temple CL, Ross DC, Bennett JD, Garvin GJ, King GJ, Faber KJ. Comparison of sagittal computed tomography and plain film radiography in a scaphoid fracture model. J Hand Surg Am. 2005 May;30(3):534-42. doi: 10.1016/j.jhsa.2005.01.001.
- Background: PubMed 15514541Breederveld RS, Tuinebreijer WE. Investigation of computed tomographic scan concurrent criterion validity in doubtful scaphoid fracture of the wrist. J Trauma. 2004 Oct;57(4):851-4. doi: 10.1097/01.ta.0000124278.29127.42.
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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.
Tim P Carey, MD, FRCSC study chair
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computerized tomography in people with Scaphoid Bone and Fracture, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 Aug 2017. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Fracture diagnosis. 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 NCT00292006, which also lists 2 linked publications.
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 23 Aug 2017.