Prognostic Impact of Neopterin on Resumption of Walking After a Fracture of the Upper Neck of the Femur in the Elderly (MAMI)
Primary Purpose
Fracture of Neck of Femur, Resumption of Walking
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Fracture of Neck of Femur focused on measuring Neopterin
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 under justice protection measure
- 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 'control':
- severe neurocognitive disorders (MMS < 15)
- fracture of the upper neck of the femur in the last year
Sites / Locations
- GH Pitié-Salpêtrière / Service de gériatrieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Fracture
Control
Arm Description
Patients with a fracture of the upper neck of the femur
Patients with no fracture of the upper neck of the femur
Outcomes
Primary Outcome Measures
Resumption of walking with or without help
Speed walk over 4 meters
Secondary Outcome Measures
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.
Hand-grip test
Measurement of bioimpedancemetry
Measurement of grip strength and of clamp force
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.
Medical Outcome Study Short Form 12
Number of participants alive
Number of participants living at home
Comparison between participants living at home and participants living in an institution
Full Information
NCT ID
NCT05233072
First Posted
December 6, 2021
Last Updated
May 5, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT05233072
Brief Title
Prognostic Impact of Neopterin on Resumption of Walking After a Fracture of the Upper Neck of the Femur in the Elderly
Acronym
MAMI
Official Title
Prognostic Impact of Neopterin on Resumption of Walking After a Fracture of the Upper Neck of the Femur in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Neck of Femur, Resumption of Walking
Keywords
Neopterin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fracture
Arm Type
Other
Arm Description
Patients with a fracture of the upper neck of the femur
Arm Title
Control
Arm Type
Other
Arm Description
Patients with no fracture of the upper neck of the femur
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Arm 'Fracture':1 blood sample at D0, D1, D3, D7 and D30 Arm 'Control': 1 blood sample at D0
Primary Outcome Measure Information:
Title
Resumption of walking with or without help
Description
Speed walk over 4 meters
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery score
Description
The score is from 0 to 12 based on the result of three exercises: Balance, gait speed and chair stand. 12 means better outcome.
Time Frame
Day 30
Title
Hand-grip test
Time Frame
Day 30
Title
Measurement of bioimpedancemetry
Description
Measurement of grip strength and of clamp force
Time Frame
Day 30
Title
Activity of Daily Living score
Description
Score based on a 6-item questionnaire. Each item is rated 0, 0.5 or 1. 1 is the best outcome.
Time Frame
Day 30
Title
Medical Outcome Study Short Form 12
Time Frame
Day 30
Title
Number of participants alive
Time Frame
From inclusion to 6 months
Title
Number of participants living at home
Description
Comparison between participants living at home and participants living in an institution
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacques BODDAERT, MD
Phone
+331 42 16 03 12
Email
jacques.boddaert@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine Sauce, PhD
Phone
+331 40 77 98 89
Email
Delphine.Sauce@sorbonne-universite.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques BODDAERT, MD
Organizational Affiliation
GH Pitié Salpêtrière - Charles Foix
Official's Role
Principal Investigator
Facility Information:
Facility Name
GH Pitié-Salpêtrière / Service de gériatrie
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques BODDAERT, MD
Phone
+331 42 16 03 12
Email
jacques.boddaert@aphp.fr
First Name & Middle Initial & Last Name & Degree
Delphine SAUCE, PhD
Phone
+331 40 77 98 89
Email
delphine.sauce@sorbonne-universite.fr
12. IPD Sharing Statement
Learn more about this trial
Prognostic Impact of Neopterin on Resumption of Walking After a Fracture of the Upper Neck of the Femur in the Elderly
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