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

NCT ID: NCT05233072

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2025-09-30

Brief Summary

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

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.

Conditions

Fracture of Neck of Femur; Resumption of Walking

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fracture

Patients with a fracture of the upper neck of the femur

Group Type: OTHER

Blood sample

Intervention Type: OTHER

Arm 'Fracture':1 blood sample at D0, D1, D3, D7 and D30 Arm 'Control': 1 blood sample at D0

Control

Patients with no fracture of the upper neck of the femur

Group Type: OTHER

Blood sample

Intervention Type: OTHER

Arm 'Fracture':1 blood sample at D0, D1, D3, D7 and D30 Arm 'Control': 1 blood sample at D0

Interventions

Blood sample

Arm 'Fracture':1 blood sample at D0, D1, D3, D7 and D30 Arm 'Control': 1 blood sample at D0

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 75 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques BODDAERT, MD

Role: PRINCIPAL_INVESTIGATOR

GH Pitié Salpêtrière - Charles Foix

Locations

GH Pitié-Salpêtrière / Service de gériatrie

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

2021-A00976-35

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP210718

Identifier Type: -

Identifier Source: org_study_id