Incidence of Neurogenic Paraosteoarthropathies in a Population of Brain Traumatized and Spinal Cord Injured Patients and Specific Markers of Early NPOA Development

Study Overview
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Brief Summary
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Neurogenic paraosteoarthropathies are peri-articular bone formations that may occur as a result of central neurological injury. Their occurrence limits reeducation and recovery capacities. Neurogenic paraosteoarthropathies sometimes cause complications (pain, joint stiffness, vascular and nerve compression, pressure sores) in patients already suffering from severe neurological sequelae affecting functional prognosis. A lot of clinical research work has been carried out within Dr Salga team. Subsequently, a collaboration was born with fundamental research teams (Pr Levesque, Pr Le Bousse Kerdilès, Pr Banzet, Pr Genêt) allowing translational work between humans and animals. The clinical application of recent research findings now makes it possible to launch the very first prospective study on neurogenic paraosteoarthropathies.

Detailed Description
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Based on the results of collaborative and translational (human-animal) work, investigators wish to conduct the first prospective study that would allow: (i) To assess the incidence of Neurogenic paraosteoarthropathies (clinical suspicion and radiological confirmation). The prospective nature of this clinical data collection will make it possible to avoid the biases attributed to the retrospective studies conducted to date. ii) Early detection of patients at risk of developing Neurogenic paraosteoarthropathies, using specific biomarkers and clinical parameters. Early diagnosis could prevent complications and functional impact of Neurogenic paraosteoarthropathies. Investigators have chosen to restrict population to patients most at risk of developing Neurogenic paraosteoarthropathies as a result of the central neurological event in order to have 2 populations appear at the end of the study: a population with Neurogenic paraosteoarthropathies and a population without Neurogenic paraosteoarthropathies that can be compared.

Official Title
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Incidence of Neurogenic Paraosteoarthropathies (NPOA) in a Population of Brain Traumatized and Spinal Cord Injured Patients and Specific Markers of Early Neurogenic Paraosteoarthropathies Development

Conditions
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Spinal Cord Injuries, Injury, Brain, Traumatic

Intervention / Treatment
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* Other: standard of care for patient with brain trauma and spinal cord injury


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female > 18 years old, brain trauma with initial Glasgow score < 8, or brain trauma with an initial Glasgow score between 8 and 14 associated with an Injury Severity Score (ISS) > 15 and surgery within 24 hours of admission or traumatic spinal cord injury with complete neurological impairment (initial para/tetraplegia), Complete traumatic spinal cord injury. Accident less than 48 hours old Informed consent signed by the patient or a family member Exclusion Criteria: Age < 18 years, Hemorrhagic shock or blood transfusion greater than or equal to 4 red blood cells within 6 hours of the trauma (also include pre-hospital or first hospital red blood cells) Follow-up impossible over one year, Patient not living in the Paris region, Pregnant or breastfeeding woman, Patient under guardianship or curatorship, No affiliation to a social security scheme or universal mutual fund.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient with brain trauma<br>all patient with brain trauma in intensive care unit | Other: standard of care for patient with brain trauma and spinal cord injury<br>* neurological examination, examination of articulation, infectious status, respiratory status, inflammatory status,kinesitherapy<br>|
| patient with spinal cord injury<br>all patient with spinal cord injury in intensive care unit | Other: standard of care for patient with brain trauma and spinal cord injury<br>* neurological examination, examination of articulation, infectious status, respiratory status, inflammatory status,kinesitherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Neurogenic Paraosteoarthropathies | Determine the incidence of Neurogenic Paraosteoarthropathies within 9 months of a brain trauma and/or spinal cord injury | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of Neurogenic Paraosteoarthropathies development within 9 months of a brain trauma | determine the incidence of Neurogenic Paraosteoarthropathies development within 9 months of a brain trauma | 9 months | 
| the incidence of Neurogenic Paraosteoarthropathies development within 9 months of a spinal cord injury, | determine the incidence of Neurogenic Paraosteoarthropathies development within 9 months of a spinal cord injury, | 9 months | 
| correlation between biological parameters from blood/plasma, urine and cerebrospinal fluid within 15 days of a central neurological injury and the occurrence of Neurogenic Paraosteoarthropathies within 9 months of the trauma | Determine if there is an correlation between biological parameters from blood/plasma, urine and cerebrospinal fluid within 15 days of a central neurological injury and the occurrence of POAN within 9 months of the trauma | 15 days | 
| a correlation between clinical parameters identified within 9 months of the neurological event and the occurrence of Neurogenic Paraosteoarthropathies within one year of the trauma, | Determine if there is a correlation between clinical parameters identified within 9 months of the neurological event and the occurrence of Neurogenic Paraosteoarthropathies within one year of the trauma, | 12 months | 
| a clinical-biological risk score for Neurogenic Paraosteoarthropathies within 9 months of the trauma | Create a clinical-biological risk score for Neurogenic Paraosteoarthropathies within 9 months of the trauma | 9 months | 
| the prognostic performance | Calculate the prognostic performance (of POAN occurrence in the year after the trauma) for the biological parameters statistically associated with Neurogenic Paraosteoarthropathies occurrence and for the risk score | 12 months |