Fracture of Neck of FemurMAMINCT05233072
Prognostic Impact of Neopterin on Resumption of Walking After a Fracture of the Upper Neck of the Femur in the Elderly
A study testing Blood sample in people with Fracture of Neck of Femur and Resumption of Walking, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 to 110 years
- Conditions the study is for
- Fracture of Neck of Femur, Resumption of Walking
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2022to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 9Show fewer
- hospitalized in emergency in a 'UPOG' unit
- For arm 'control':
- hospitalized patient without any acute clinical event
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
GH Pitié-Salpêtrière / Service de gériatrie
Paris, Île-de-France Region, 75013
About this study
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.
Read the 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
- Being tested
- Blood sample
- Keywords
- Neopterin
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Arm 'Fracture':1 blood sample at D0, D1, D3, D7 and D30 Arm 'Control': 1 blood sample at D0
| Study group | Role | What they receive |
|---|---|---|
| Fracture | Other | Patients with a fracture of the upper neck of the femur Receives: Other: Blood sample |
| Control | Other | Patients with no fracture of the upper neck of the femur Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resumption of walking with or without help
Speed walk over 4 meters
Measured: Day 30
Secondary outcomes (7)
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.
Measured: Day 30
Hand-grip test
Measured: Day 30
Measurement of bioimpedancemetry
Measurement of grip strength and of clamp force
Measured: 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.
Measured: Day 30
Medical Outcome Study Short Form 12
Measured: Day 30
Number of participants alive
Measured: From inclusion to 6 months
Number of participants living at home
Comparison between participants living at home and participants living in an institution
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start16 May 2022
- Primary completion15 Nov 2024
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Neck of FemurStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques BODDAERT, MD, Principal investigator, GH Pitié Salpêtrière - Charles Foix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233072
- Sponsor's protocol ID
- APHP210718
- Other IDs
- 2021-A00976-35
- Acronym
- MAMI
- Status last verified
- Feb 2025
- First submitted
- 6 Dec 2021
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Neopterin on Resumption of Walking After a Fracture of the Upper Neck of the Femur in the Elderly
- ClinicalTrials.gov ID
- NCT05233072
- Acronym / sponsor ID
- MAMI / APHP210718
- Conditions
- Fracture of Neck of Femur, Resumption of Walking
- Keywords
- Neopterin
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 16 May 2022 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fracture | Other | Other: Blood samplePatients with a fracture of the upper neck of the femur |
| Control | Other | Other: Blood samplePatients with no fracture of the upper neck of the femur |
Who may qualify
- Ages
- 75 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- age over 75
- affiliated to health insurance system
- written informed consent
- patient with a fracture of the upper neck of the femur
- hospitalized in emergency in a 'UPOG' unit
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleArm 'Fracture':1 blood sample at D0, D1, D3, D7 and D30 Arm 'Control': 1 blood sample at D0 | Other | Control, Fracture |
Primary outcome
Resumption of walking with or without help
Time frame: Day 30
Speed walk over 4 meters
7 secondary outcomes
Short Physical Performance Battery score
Time frame: Day 30
Hand-grip test
Time frame: Day 30
Measurement of bioimpedancemetry
Time frame: Day 30
Activity of Daily Living score
Time frame: Day 30
Medical Outcome Study Short Form 12
Time frame: Day 30
Number of participants alive
Time frame: From inclusion to 6 months
Number of participants living at home
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques BODDAERT, MD principal investigator
GH Pitié Salpêtrière - Charles Foix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Fracture of Neck of Femur and Resumption of Walking, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resumption of walking with or without help (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.