Acetabular FractureNCT03316235
New, Easy and Efficient Ways to CLassify AcetabulaR Fractures
An observational study of Acetabular Fracture, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Acetabular fractures are the resultant from high-energy trauma or low-energy trauma in the elder patients. Usually, surgeons use LETOURNEL's classification or/and JUDET's one. Five elements are considered and associated to five type of fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Fracture
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2016to 30 Oct 2016
- Phase
- Observational
- 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
Study population: patients with acetabular fracture surgery
Who may be able to join
- acetabular fracture
Who cannot join
- no criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Acetabular fractures are the resultant from high-energy trauma or low-energy trauma in the elder patients. Usually, surgeons use LETOURNEL's classification or/and JUDET's one.
Five elements are considered and associated to five type of fracture. Even more, for orthopaedic surgeons with less experience with these fractures, correct classification can be more difficult.
Read more
So the the aim of this study is:
- Evaluate the efficacy of four "special" 3D reconstruction: a 3D reconstruction of the pelvis with anterior view, posterior view, endopelvic view where the opposite hemipelvis removed and an exopelvic view where the femoral head is removed according to the initial teaching of E. Letournel.
- Evaluate the addition of teaching of non-experimented surgeon on the accuracy of classifying acetabular fractures.
- Evaluate the addition of a digital algorithm (mobile application) on the accuracy of classifying acetabular fractures.
Read the detailed description
12 reviewers will be given the different imaging of each case and will be divided in 4 groups: novice (junior ER and ortho residents), intermediate (non-experimented orthopedic surgeons), intermediate with a formation on classifying acetabular fractures and finally experts (acetabular fracture expert surgeons) . For each patient, representative CT scans are provided for each assessment. The study will be divided into 3 phases separated by 4-6 weeks of time. In the first phase, for each patient, representative CT scans are provided for each assessment with 2D and multiplanar reconstruction (MPR) without 3D views. In the second phase, 3D views are added. In the third phase, the cases are evaluated using the "Acetabular Diagnosis Tool" To note, the evaluation of the cases is done twice in each phase separated by 4-6 weeks and the order of the cases is changed, both in order to minimize recall bias
- Conditions
- Acetabular Fracture
What is being measured
The primary outcome is the main question the study is designed to answer.
3D reconstruction of pelvis CT scan
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start27 May 2016
- Primary completion31 Aug 2016
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316235
- Sponsor's protocol ID
- CLARIFY
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New, Easy and Efficient Ways to CLassify AcetabulaR Fractures
- ClinicalTrials.gov ID
- NCT03316235
- Acronym / sponsor ID
- CLARIFY
- Conditions
- Acetabular Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 27 May 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 20 Oct 2017 (actual)
- 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.
Acetabular fractures are the resultant from high-energy trauma or low-energy trauma in the elder patients. Usually, surgeons use LETOURNEL's classification or/and JUDET's one.
Five elements are considered and associated to five type of fracture. Even more, for orthopaedic surgeons with less experience with these fractures, correct classification can be more difficult.
So the the aim of this study is:
- Evaluate the efficacy of four "special" 3D reconstruction: a 3D reconstruction of the pelvis with anterior view, posterior view, endopelvic view where the opposite hemipelvis removed and an exopelvic view where the femoral head is removed according to the initial teaching of E. Letournel.
- Evaluate the addition of teaching of non-experimented surgeon on the accuracy of classifying acetabular fractures.
- Evaluate the addition of a digital algorithm (mobile application) on the accuracy of classifying acetabular fractures.
Detailed description
12 reviewers will be given the different imaging of each case and will be divided in 4 groups: novice (junior ER and ortho residents), intermediate (non-experimented orthopedic surgeons), intermediate with a formation on classifying acetabular fractures and finally experts (acetabular fracture expert surgeons) . For each patient, representative CT scans are provided for each assessment. The study will be divided into 3 phases separated by 4-6 weeks of time. In the first phase, for each patient, representative CT scans are provided for each assessment with 2D and multiplanar reconstruction (MPR) without 3D views. In the second phase, 3D views are added. In the third phase, the cases are evaluated using the "Acetabular Diagnosis Tool" To note, the evaluation of the cases is done twice in each phase separated by 4-6 weeks and the order of the cases is changed, both in order to minimize recall bias
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acetabular fracture surgery
Key inclusion criteria (1 listed)
- acetabular fracture
Key exclusion criteria (1 listed)
- no criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3D reconstruction of pelvis CT scan
Time frame: 6 months
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 20 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acetabular Fracture, run by Fondation Hôpital Saint-Joseph 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 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: finished, as of the sponsor's last update on 20 Oct 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 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?
3D reconstruction of pelvis CT scan (time frame: 6 months). 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 20 Oct 2017.