Prognostic Impact of Neopterin on Resumption of Walking After a Fracture of the Upper Neck of the Femur in the Elderly

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prognostic Impact of Neopterin on Resumption of Walking After a Fracture of the Upper Neck of the Femur in the Elderly

Conditions
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Fracture of Neck of Femur, Resumption of Walking

Intervention / Treatment
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* Other: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For both arms: age over 75 affiliated to health insurance system written informed consent For arm 'Fracture': patient with a fracture of the upper neck of the femur hospitalized in emergency in a 'UPOG' unit For arm 'control': hospitalized patient without any acute clinical event Exclusion Criteria: For both arms: polytrauma pathological bone or prothesis fracture patient affiliated to 'Aide Médical de l'Etat - AME' insurance patient with immunosuppressant treatment (including corticotherapy over 5 mg/d) patient with active solid cancer or malignant haemopathy patient with auto-immune disease refusal to participate in research For arm 'Fracture': patient under justice protection measure except tutorship and guardianship For arm 'control': severe neurocognitive disorders (MMS < 15) fracture of the upper neck of the femur in the last year patient under justice protection measure

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fracture<br>Patients with a fracture of the upper neck of the femur | Other: Blood sample<br>* Arm 'Fracture':1 blood sample at D0, D1, D3, D7 and D30 Arm 'Control': 1 blood sample at D0<br>|
| Other: Control<br>Patients with no fracture of the upper neck of the femur | Other: Blood sample<br>* Arm 'Fracture':1 blood sample at D0, D1, D3, D7 and D30 Arm 'Control': 1 blood sample at D0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resumption of walking with or without help | Speed walk over 4 meters | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neopterin