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

Assistance Publique - Hôpitaux de Paris118 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

118

Conditions

Spinal Cord Injuries Injury, Brain, Traumatic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of Neurogenic Paraosteoarthropathies

Determine the incidence of Neurogenic Paraosteoarthropathies within 9 months of a brain trauma and/or spinal cord injury

Time frame: 9 months

Secondary Outcomes

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

Time frame: 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,

Time frame: 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

Time frame: 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,

Time frame: 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

Time frame: 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

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts