AcetabulumACETABULUMNCT02848924
Current Incidence and Treatments Performed of Fractures of the Acetabulum and Pelvis in France in 2013
An observational study of Acetabulum and Fractures, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Fractures of the acetabulum and pelvis are serious injuries to vital prognostic can play in cases of severe bleeding. In all cases the functional is a major issue with a potential reach of walking ability and maintaining the seated and standing positions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acetabulum, Fractures
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Feb 2015
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients hospitalized for broken pelvis and acetabulum in France
Who may be able to join
- All patients
Who cannot join
- No exclusion 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
Fractures of the acetabulum and pelvis are serious injuries to vital prognostic can play in cases of severe bleeding. In all cases the functional is a major issue with a potential reach of walking ability and maintaining the seated and standing positions. The treatment of such lesions requires management to a specialist, or the ability to use such centers for advice or transferring patients. This organization was recommended after the symposium of the French Society of Orthopedic Surgery (SOFCOT) in 2009. With the aging population, the incidence and clinical features of these fractures have evolved to worsening the functional prognosis. Club Basin acetabulum, body SOFCOT, wants to achieve an observational study assessing needs and practices at national and regional level. The long-term objective is to propose a regional organization of care of these patients in order to reduce morbidity and mortality associated.
Read the detailed description
Fractures of the acetabulum and pelvis are serious injuries to vital prognostic can play in cases of severe bleeding. In all cases the functional is a major issue with a potential reach of walking ability and maintaining the seated and standing positions. The treatment of such lesions requires management to a specialist, or the ability to use such centers for advice or transferring patients. This organization was recommended after the symposium of the French Society of Orthopedic Surgery (SOFCOT) in 2009. With the aging population, the incidence and clinical features of these fractures have evolved to worsening the functional prognosis. Club Basin acetabulum, body SOFCOT, wants to achieve an observational study assessing needs and practices at national and regional level. The long-term objective is to propose a regional organization of care of these patients in order to reduce morbidity and mortality associated.
FORMAT OF RESEARCH retrospective observational study of SNIIRAM data on hospitalizations for broken pelvis and acetabulum (CCAM codes S32.40 / S32.41 / S32.30 / S32.31 / S32.10 / S32.11 / S32.50 / S32 .51 / S32.70 / S32.71 / S32.80 / S32.81), with collection of the following data:
- Patient demographics: age, sex, comorbidities (DRG coding), place of residence.
- Length of hospital stay
- Treatment undertaken: CCAM coding during hospitalization
- Mortality at 30 days and 1 year.
- Conditions
- Acetabulum, Fractures
- Being tested
- No intervention
- Keywords
- prevalence, surgery, Treatments
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of hospital stay length from medical file
Measured: Day 1 after hospitalization
Assesment of change of mortality
Assesment of change of mortality in this point time using a phone call.
Measured: Day 30 and 1 year after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcetabulumStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JOUFFROY Pommes, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848924
- Sponsor's protocol ID
- ACETABULUM
- Acronym
- ACETABULUM
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Incidence and Treatments Performed of Fractures of the Acetabulum and Pelvis in France in 2013
- ClinicalTrials.gov ID
- NCT02848924
- Acronym / sponsor ID
- ACETABULUM / ACETABULUM
- Conditions
- Acetabulum, Fractures
- Keywords
- prevalence, surgery, Treatments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 29 Jul 2016 (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.
Fractures of the acetabulum and pelvis are serious injuries to vital prognostic can play in cases of severe bleeding. In all cases the functional is a major issue with a potential reach of walking ability and maintaining the seated and standing positions. The treatment of such lesions requires management to a specialist, or the ability to use such centers for advice or transferring patients. This organization was recommended after the symposium of the French Society of Orthopedic Surgery (SOFCOT) in 2009. With the aging population, the incidence and clinical features of these fractures have evolved to worsening the functional prognosis. Club Basin acetabulum, body SOFCOT, wants to achieve an observational study assessing needs and practices at national and regional level. The long-term objective is to propose a regional organization of care of these patients in order to reduce morbidity and mortality associated.
Detailed description
Fractures of the acetabulum and pelvis are serious injuries to vital prognostic can play in cases of severe bleeding. In all cases the functional is a major issue with a potential reach of walking ability and maintaining the seated and standing positions. The treatment of such lesions requires management to a specialist, or the ability to use such centers for advice or transferring patients. This organization was recommended after the symposium of the French Society of Orthopedic Surgery (SOFCOT) in 2009. With the aging population, the incidence and clinical features of these fractures have evolved to worsening the functional prognosis. Club Basin acetabulum, body SOFCOT, wants to achieve an observational study assessing needs and practices at national and regional level. The long-term objective is to propose a regional organization of care of these patients in order to reduce morbidity and mortality associated.
FORMAT OF RESEARCH retrospective observational study of SNIIRAM data on hospitalizations for broken pelvis and acetabulum (CCAM codes S32.40 / S32.41 / S32.30 / S32.31 / S32.10 / S32.11 / S32.50 / S32 .51 / S32.70 / S32.71 / S32.80 / S32.81), with collection of the following data:
- Patient demographics: age, sex, comorbidities (DRG coding), place of residence.
- Length of hospital stay
- Treatment undertaken: CCAM coding during hospitalization
- Mortality at 30 days and 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients hospitalized for broken pelvis and acetabulum in France
Key inclusion criteria (1 listed)
- All patients
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Assessment of hospital stay length from medical file
Time frame: Day 1 after hospitalization
Assesment of change of mortality
Time frame: Day 30 and 1 year after hospitalization
Assesment of change of mortality in this point time using a phone call.
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 29 Jul 2016.
Related trials for Acetabulum
Active, not recruitingPhase 2
Stoppa Approach Vs Anterior & Posterior Fixation in Management of BC Fracture Acetabulum
Evaluation of Isolated Stoppa Approach in BC Fracture Acetabulum
Enrolling by invitation
Virtual Reality-Based Simulation Training for Retrograde Anterior Column Acetabular Screw Placement in Orthopedic Residents
Virtual Reality Simulation
Not yet recruitingPhase 1/2
PROactive HEALing in High-Risk Pelvic and Non-hip Lower Extremity Fragility Fractures (PRO HEAL Pilot)
Lower Extremity Fractures, Pelvis
RecruitingObservational study
Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty
Hip Fractures, Hip Hemiarthroplasty
Not yet recruiting
Weight Bearing After Pelvis and Acetabulum Fracture Fixation
Pelvis Fractures, Acetabulum Fractures
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.
JOUFFROY Pommes, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Acetabulum and Fractures, 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 29 Jul 2016. 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?
Assessment of hospital stay length from medical file (time frame: Day 1 after hospitalization). 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 29 Jul 2016.