Femoral FracturePAAFNCT03810092
Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur
An observational study of Femoral Fracture, run by Centre Hospitalier Departemental Vendee at 5 sites in France.
Trial summary
Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Femoral Fracture
- How many people
- 255 participants
- Where
- 5 sitesFrance
- Study dates
- 20 May 2019to 12 Apr 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This study is intended for patients over 75 years of age who have had a fracture of the upper extremity of the femur operated on.
Who may be able to join
- Age ≥ 75 years
- Patient operated on a fracture of the upper extremity of the femur
- Patient, family or close relative who does not object to participation in the study
- Patient affiliated to a social security system
- Patient who can be monitored as part of the protocol
Who cannot join
- Refusal to participate in the study (patient, family or trusted relative)
- Patient with support on the operated limb not authorized by the surgeon
- Patient with an associated fracture (polytrauma, concomitant trauma to the upper limb...)
- Patient with a pathologic fracture
- Patient included in Category 1 interventional research (involving a drug or medical device)
- Patient deprived of liberty
- Patient not affiliated to a social security system
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Angers
Angers
CH Cholet
Cholet
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon
CH La Rochelle
La Rochelle
CH Saint Malo
St-Malo
About this study
Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. In this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.
- Conditions
- Femoral Fracture
- Medical subject headings
- Femoral Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Rate
Measured: 5 days after surgery
Questionnaire Activities of Daily Living
For each question, a point from 0 (worst value) to 1 (best value) is assigned. The total score is 6 points.
A loss of autonomy will be defined by the decrease of one or more points in the ADL.
Result showed here is the difference of ADL score intra patient
Measured: Pre-fractural and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start20 May 2019
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Femoral 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
- Other
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain DECOURS, Principal investigator, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810092
- Sponsor's protocol ID
- CHD117-17
- Acronym
- PAAF
- Status last verified
- Sep 2025
- First submitted
- 17 Jan 2019
- Last updated
- 19 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur
- ClinicalTrials.gov ID
- NCT03810092
- Acronym / sponsor ID
- PAAF / CHD117-17
- Conditions
- Femoral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Posted 19 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. In this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This study is intended for patients over 75 years of age who have had a fracture of the upper extremity of the femur operated on.
Key inclusion criteria (5 listed)
- Age ≥ 75 years
- Patient operated on a fracture of the upper extremity of the femur
- Patient, family or close relative who does not object to participation in the study
- Patient affiliated to a social security system
- Patient who can be monitored as part of the protocol
Key exclusion criteria (7 listed)
- Refusal to participate in the study (patient, family or trusted relative)
- Patient with support on the operated limb not authorized by the surgeon
- Patient with an associated fracture (polytrauma, concomitant trauma to the upper limb...)
- Patient with a pathologic fracture
- Patient included in Category 1 interventional research (involving a drug or medical device)
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
Hemoglobin Rate
Time frame: 5 days after surgery
Questionnaire Activities of Daily Living
Time frame: Pre-fractural and 6 months after surgery
For each question, a point from 0 (worst value) to 1 (best value) is assigned. The total score is 6 points. A loss of autonomy will be defined by the decrease of one or more points in the ADL. Result showed here is the difference of ADL score intra patient
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Romain DECOURS principal investigator
CHD Vendée
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Fracture, run by Centre Hospitalier Departemental Vendee at 5 sites 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 5 inclusion and 7 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 19 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin Rate (time frame: 5 days after surgery). 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 19 Sep 2025.