Femoral Fracture
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Rate | 5 days after surgery | — |
| Questionnaire Activities of Daily Living | 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 |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intent to Treat Population Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur | 238 |
| Total | 238 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | ADL not done at J0 | 16 |
| Overall Study | no ground support | 17 |
| Overall Study | No hemoglobin measure at J5 | 27 |
Baseline characteristics
| Characteristic | Intent to Treat Population | — |
|---|---|---|
| Age, Continuous | 88 years | — |
| Anterior fracture | 81 Participants | — |
| BMI | 23 kg/m² | — |
| Hospitalisation time | 6 days | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 181 Participants | — |
| Sex: Female, Male Male | 57 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 37 / 238 |
| other Total, other adverse events | 0 / 238 |
| serious Total, serious adverse events | 0 / 238 |
Outcome results
Primary
Hemoglobin Rate
Time frame: 5 days after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intent to Treat Population | Hemoglobin Rate | 10 g/dl |
Primary
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
Time frame: Pre-fractural and 6 months after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intent to Treat Population | Questionnaire Activities of Daily Living | 1 score on a scale |
Comparison: Relationship between ADL score evolution and hemoglobine rate, in the no transfusion groupp-value: 0.0595% CI: [-0.55, 0.42]Regression, Linear
Comparison: Relationship between ADL score evolution and hemoglobine rate, in the transfusion groupp-value: 0.0595% CI: [-1, 2.2]Regression, Logistic