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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00976-35 | Registry Identifier | DRCB |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Society faces a major challenge with the management of the health and socio-economic burden caused by acute physical stress in the older population (>75 years). In particular, hip fracture (HF) represents a major health care preoccupation, affecting 1.6 M patients worldwide, resulting in a significant drop of life quality and autonomy. Nowadays, this trauma is still associated with a poor outcome of 20-30% one-year mortality in the elderly. This emphasizes the value of assessing biological factors that may predict clinical outcome after HF. The preliminary work pinpoints a central role of neopterin in loss of autonomy and death. Using HF as an acute stress model that accelerates the progressive course of aging, the aim is to validate neopterin as a predictive biomarker of pernicious clinical outcomes.
Hip fracture (HF) is a common condition affecting an estimated 2 million older people worldwide and that number is increasing by 25% each decade as the population continues to grow. HF has serious clinical consequences due to the associated morbidity, the loss of autonomy in individuals generally autonomous before the event. HF has also been shown to be an independent predictor of a new admission to long-term care, representing an unfavorable outcome with annual costs of four billion in the United States alone. Among the avenues aimed at improving the management of HF, the deployment of perioperative geriatric units (UPOG) has improved the prognosis of patients but their implantations are still unfortunately too marginal. It is therefore in the identification of patients most at risk that research must be focused in order to identify the most vulnerable and target interventions. Today, the decision of admission is made early in the course of care, as soon as their arrival to emergencies, and involves discussion between orthopedist, anesthesiologist and geriatrician. This decision is based on criteria that are still very logistical (place or not), clinical (comorbidities, fragility, severity, etc.) but lacks objective information (no predictive signatures) on resilience post HF.
In this context, prognostic biomarkers would have an important role to play in guiding clinicians. The investigators team has shown that neopterin is a biomarker of inflammation and activation of the immune system secreted during HF and whose increased rate has been associated with mortality at one year post HF as well as with functional recovery on D30 after surgery.
The investigators hypothesize that the neopterin measured at the admission of the elderly patient to the emergency ward for HF could improve the prediction of the resumption of walking without major loss of autonomy at D30 after surgery.
The main objective of the study is to assess whether the plasma neopterin concentration can predict the resumption of walking on D30 after surgery, in elderly patients who have undergone surgery as part of a HF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fracture | Other | Patients with a fracture of the upper neck of the femur |
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| Control | Other | Patients with no fracture of the upper neck of the femur |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | Arm 'Fracture':1 blood sample at D0, D1, D3, D7 and D30 Arm 'Control': 1 blood sample at D0 |
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| Measure | Description | Time Frame |
|---|---|---|
| Resumption of walking with or without help | Speed walk over 4 meters | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Short Physical Performance Battery score | The score is from 0 to 12 based on the result of three exercises: Balance, gait speed and chair stand. 12 means better outcome. | Day 30 |
| Hand-grip test |
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Inclusion Criteria:
For both arms:
For arm 'Fracture':
For arm 'control':
Exclusion Criteria:
For both arms:
For arm 'Fracture':
For arm 'control':
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| Name | Affiliation | Role |
|---|---|---|
| Jacques BODDAERT, MD | GH Pitié Salpêtrière - Charles Foix | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GH Pitié-Salpêtrière / Service de gériatrie | Paris | Île-de-France Region | 75013 | France |
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Day 30 |
| Measurement of bioimpedancemetry | Measurement of grip strength and of clamp force | Day 30 |
| Activity of Daily Living score | Score based on a 6-item questionnaire. Each item is rated 0, 0.5 or 1. 1 is the best outcome. | Day 30 |
| Medical Outcome Study Short Form 12 | Day 30 |
| Number of participants alive | From inclusion to 6 months |
| Number of participants living at home | Comparison between participants living at home and participants living in an institution | Month 6 |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |