Femur FractureFESF-AmiensNCT03117868
Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens
An observational study of Femur Fracture and Morality, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Fractures of the upper femur (EFSF) represent a major public health problem in the elderly. Approximately 1.6 million patients are victims each year of an EFSF and this number is increasing as a result of the aging of the population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture, Morality
- What is being tested?
- Study of mortality at 6 months
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2016to 28 Nov 2017
- 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: All the patients operated with an EFSF and meeting the inclusion criteria
Who may be able to join
- All the patients operated from a fracture of traumatic origin of the ESF to the emergency block at the CHU of Amiens
- Patients transferred to the CHU after being cared for in another structure will be included.
- If a patient successively presents a fracture of each upper extremity of the femur outside of a surgical resumption, two inclusions will be realized
Who cannot join
- Do not include non-traumatic fractures of the upper end of the femur (pathological fractures: cancer, for example)
- Fractures of the upper end of the femur associated with polytrauma will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Fractures of the upper femur (EFSF) represent a major public health problem in the elderly. Approximately 1.6 million patients are victims each year of an EFSF and this number is increasing as a result of the aging of the population.
In a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of the fracture. In surviving patients, the impact on loss of autonomy and degradation of quality of life is considerable.
Read more
The reduction of the incidence of post-operative complications includes the identification of risk factors.
No prospective study in Amiens has investigated the mortality and the study of the variables involved in the prognosis and long-term mortality of these patients.
- Conditions
- Femur Fracture, Morality
- Being tested
- Study of mortality at 6 months
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of mortality at 6 monthsOther
The objective is to provide strong arguments for establishing a dynamic of collective care for patients suffering from an EFSF
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 6 months of EFSF patients
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 posted18 Apr 2017
- Study start2 Jun 2016
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117868
- Sponsor's protocol ID
- RNI2016-04
- Acronym
- FESF-Amiens
- Status last verified
- Jul 2020
- First submitted
- 13 Apr 2017
- Last updated
- 20 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens
- ClinicalTrials.gov ID
- NCT03117868
- Acronym / sponsor ID
- FESF-Amiens / RNI2016-04
- Conditions
- Femur Fracture, Morality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 18 Apr 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.
Fractures of the upper femur (EFSF) represent a major public health problem in the elderly. Approximately 1.6 million patients are victims each year of an EFSF and this number is increasing as a result of the aging of the population.
In a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of the fracture. In surviving patients, the impact on loss of autonomy and degradation of quality of life is considerable.
The reduction of the incidence of post-operative complications includes the identification of risk factors.
No prospective study in Amiens has investigated the mortality and the study of the variables involved in the prognosis and long-term mortality of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients operated with an EFSF and meeting the inclusion criteria
Key inclusion criteria (3 listed)
- All the patients operated from a fracture of traumatic origin of the ESF to the emergency block at the CHU of Amiens
- Patients transferred to the CHU after being cared for in another structure will be included.
- If a patient successively presents a fracture of each upper extremity of the femur outside of a surgical resumption, two inclusions will be realized
Key exclusion criteria (2 listed)
- Do not include non-traumatic fractures of the upper end of the femur (pathological fractures: cancer, for example)
- Fractures of the upper end of the femur associated with polytrauma will not be included.
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 |
|---|---|---|
| Study of mortality at 6 monthsThe objective is to provide strong arguments for establishing a dynamic of collective care for patients suffering from an EFSF | Other | – |
Primary outcome
Mortality at 6 months of EFSF patients
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 Jul 2020.
Related trials for Femur Fracture
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
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 Femur Fracture and Morality, run by Centre Hospitalier Universitaire, Amiens 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 3 inclusion and 2 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 Jul 2020. 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?
Mortality at 6 months of EFSF patients (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 Jul 2020.