Scaphoid Bone Fracture SuspicionNCT01235806
Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures
A study testing MRI in people with Scaphoid Bone Fracture Suspicion, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The Alpes Maritimes county administration (France) equipped Nice University Hospital of a 0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the medical imaging unit. The aim of our project is to study its interest in diagnosis of scaphoid fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scaphoid Bone Fracture Suspicion
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Mar 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical suspicion of scaphoid bone fracture, whatever the radiologic check-up result is.
- Major patient who signed the informed consent form.
- Patient affiliated to French national health and pensions organization. NON INCLUSION
- MRI contraindication.
- No pain.
- No traumatic antecedent.
Show all 11Show fewer
- Pregnant or suckler women.
- Patient under a guardianship or a trusteeship
- Patient deprived of liberty consequently to a judiciary procedure
- Patient holding a pace-maker
- Patient holding a foreign body or ferromagnetic prosthetic material.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital
Nice, 06000
About this study
Official title: Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures.
The Alpes Maritimes county administration (France) equipped Nice University Hospital of a 0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the medical imaging unit.
The aim of our project is to study its interest in diagnosis of scaphoid fractures.
Read more
Conventional medical care for patients being suspected to have a scaphoid fracture consists in performing a clinical examination and a radiographic check-up with at least 4 incidences, which 2 specific incidences for the scaphoid bone.
Yet, this check up is sometimes defective, causing false positives unnecessary immobilisation and false negatives delays in patient medical care, increasing the risk of complication. Those diagnosis mistakes can bring serious consequences, from permanent partial inability, to professional reclassification.
Alternative imaging exists, but is often irradiating, and never reaches the optimal specificity and sensitivity.
MRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of cases. The problem is the lack of accessibility for emergency cases; therefore there is a great interest in validating the use of a MRI dedicated to distal articulations.
The few studies that study costs of diagnosis strategies including MRI in scaphoid bone fractures diagnosis show a reduction of medical costs if this technique is used early. Our project represents an essential initial step in evaluating the impact of a low field MRI dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will be a medico-economical study, since scaphoid fractures occur frequently.
Finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.
- Conditions
- Scaphoid Bone Fracture Suspicion
- Being tested
- MRI
- Keywords
- scaphoid, MRI, ESAOTE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
MRI of the scaphoid bone fracture suspicion
| Study group | Role | What they receive |
|---|---|---|
| MRI | Other | MRI of the scaphoid bone fracture suspicion Receives: Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI and radiography interpretation items
comparaison between MRI and radiography interpretation items
Measured: The day of the scaphoid fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startMar 2009
- Primary completionMar 2009
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scaphoid Bone Fracture SuspicionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas AMORETTI, MD, Principal investigator, Medical and interventionnal Imaging Unit, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235806
- Sponsor's protocol ID
- 07-CPR-01
- Status last verified
- Sep 2015
- First submitted
- 5 Nov 2010
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures.
- ClinicalTrials.gov ID
- NCT01235806
- Acronym / sponsor ID
- 07-CPR-01
- Conditions
- Scaphoid Bone Fracture Suspicion
- Keywords
- scaphoid, MRI, ESAOTE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 8 Nov 2010 (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 Alpes Maritimes county administration (France) equipped Nice University Hospital of a 0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the medical imaging unit.
The aim of our project is to study its interest in diagnosis of scaphoid fractures.
Conventional medical care for patients being suspected to have a scaphoid fracture consists in performing a clinical examination and a radiographic check-up with at least 4 incidences, which 2 specific incidences for the scaphoid bone.
Yet, this check up is sometimes defective, causing false positives unnecessary immobilisation and false negatives delays in patient medical care, increasing the risk of complication. Those diagnosis mistakes can bring serious consequences, from permanent partial inability, to professional reclassification.
Alternative imaging exists, but is often irradiating, and never reaches the optimal specificity and sensitivity.
MRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of cases. The problem is the lack of accessibility for emergency cases; therefore there is a great interest in validating the use of a MRI dedicated to distal articulations.
The few studies that study costs of diagnosis strategies including MRI in scaphoid bone fractures diagnosis show a reduction of medical costs if this technique is used early. Our project represents an essential initial step in evaluating the impact of a low field MRI dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will be a medico-economical study, since scaphoid fractures occur frequently.
Finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Other | Radiation: MRIMRI of the scaphoid bone fracture suspicion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clinical suspicion of scaphoid bone fracture, whatever the radiologic check-up result is.
- Major patient who signed the informed consent form.
- Patient affiliated to French national health and pensions organization. NON INCLUSION
- MRI contraindication.
- No pain.
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 |
|---|---|---|
| MRIMRI of the scaphoid bone fracture suspicion | Radiation | MRI |
Primary outcome
MRI and radiography interpretation items
Time frame: The day of the scaphoid fracture
comparaison between MRI and radiography interpretation items
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 30 Sep 2015.
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.
Nicolas AMORETTI, MD principal investigator
Medical and interventionnal Imaging Unit, Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Scaphoid Bone Fracture Suspicion, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 11 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 30 Sep 2015. 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 France. 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?
MRI and radiography interpretation items (time frame: The day of the scaphoid fracture). 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 30 Sep 2015.