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

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Spinal Cord Injuries

Injury, Brain, Traumatic

Treatments

Other: standard of care for patient with brain trauma and spinal cord injury

Study type

Observational

Funder types

Other

Identifiers

NCT04273347

APHP190623

Details and patient eligibility

About

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.

Full description

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.

Enrollment

118 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.