Acetabular FractureNCT03305640
Identification of an Atypical acetabuLar frActure With an Independent Roof Component: Incidence and Description
An observational study of Acetabular Fracture, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Treatment of acetabular fractures needs a perfect diagnosis to anticipate surgical difficulties. E. Letournel described a rare atypical both-column fracture which " introduces enormous surgical difficulties ". Its particularity is a sagittal comminution interesting the acetabular roof. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acetabular Fracture
- What is being tested?
- acetabular fracture surgery
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2016to 31 Dec 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: every patient with acute acetabular fractures managed in a single institution between 2007 and 2013
Who may be able to join
- patient with acetabular fracture
Who cannot join
- other type of fracture
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
Treatment of acetabular fractures needs a perfect diagnosis to anticipate surgical difficulties. E. Letournel described a rare atypical both-column fracture which " introduces enormous surgical difficulties ". Its particularity is a sagittal comminution interesting the acetabular roof.
In this experience the particular fracture is probably under-diagnosed. The purpose of this study is to give the exact incidence and a precise description of these fractures to improve their surgical management.
- Conditions
- Acetabular Fracture
- Being tested
- acetabular fracture surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetabular fracture surgeryProcedure or surgery
acetabular fracture surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of volume-rendered 3D-CT images on preoperative CT-scans
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start27 May 2016
- Primary completion31 Aug 2016
- Study completion31 Dec 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
- Investigators
- Pomme JOUFFROY, MD, Principal investigator, GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305640
- Sponsor's protocol ID
- ALARIC
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 10 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 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of an Atypical acetabuLar frActure With an Independent Roof Component: Incidence and Description
- ClinicalTrials.gov ID
- NCT03305640
- Acronym / sponsor ID
- ALARIC
- 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
- 31 Dec 2016 (actual)
- First posted
- 10 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.
Treatment of acetabular fractures needs a perfect diagnosis to anticipate surgical difficulties. E. Letournel described a rare atypical both-column fracture which " introduces enormous surgical difficulties ". Its particularity is a sagittal comminution interesting the acetabular roof.
In this experience the particular fracture is probably under-diagnosed. The purpose of this study is to give the exact incidence and a precise description of these fractures to improve their surgical management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- every patient with acute acetabular fractures managed in a single institution between 2007 and 2013
Key inclusion criteria (1 listed)
- patient with acetabular fracture
Key exclusion criteria (1 listed)
- other type of fracture
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 |
|---|---|---|
| acetabular fracture surgeryacetabular fracture surgery | Procedure or surgery | – |
Primary outcome
measurement of volume-rendered 3D-CT images on preoperative CT-scans
Time frame: Day 1
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 10 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.
Pomme JOUFFROY, MD principal investigator
GHPSJ
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 10 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?
measurement of volume-rendered 3D-CT images on preoperative CT-scans (time frame: Day 1). 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 10 Oct 2017.