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

NCT ID: NCT04273347

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-12-15

Brief Summary

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

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.

Conditions

Spinal Cord Injuries; Injury, Brain, Traumatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patient with brain trauma

all patient with brain trauma in intensive care unit

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

Intervention Type: OTHER

neurological examination, examination of articulation, infectious status, respiratory status, inflammatory status,kinesitherapy

patient with spinal cord injury

all patient with spinal cord injury in intensive care unit

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

Intervention Type: OTHER

neurological examination, examination of articulation, infectious status, respiratory status, inflammatory status,kinesitherapy

Interventions

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

neurological examination, examination of articulation, infectious status, respiratory status, inflammatory status,kinesitherapy

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Majorie Salga, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Raymond Poincaré

Central Contacts

Marjorie salga, MD

Role: CONTACT

marjorie.salga@aphp.fr

+33 1 47 10 70 82

François Genet, Professor

Role: CONTACT

francois.genet@aphp.fr

+331 47 10 70 70

References

Torossian F, Guerton B, Anginot A, Alexander KA, Desterke C, Soave S, Tseng HW, Arouche N, Boutin L, Kulina I, Salga M, Jose B, Pettit AR, Clay D, Rochet N, Vlachos E, Genet G, Debaud C, Denormandie P, Genet F, Sims NA, Banzet S, Levesque JP, Lataillade JJ, Le Bousse-Kerdiles MC. Macrophage-derived oncostatin M contributes to human and mouse neurogenic heterotopic ossifications. JCI Insight. 2017 Nov 2;2(21):e96034. doi: 10.1172/jci.insight.96034.

Reference Type: RESULT

PMID: 29093266 (View on PubMed)

Reznik JE, Biros E, Marshall R, Jelbart M, Milanese S, Gordon S, Galea MP. Prevalence and risk-factors of neurogenic heterotopic ossification in traumatic spinal cord and traumatic brain injured patients admitted to specialised units in Australia. J Musculoskelet Neuronal Interact. 2014 Mar;14(1):19-28.

Reference Type: RESULT

PMID: 24583537 (View on PubMed)

Other Identifiers

APHP190623

Identifier Type: -

Identifier Source: org_study_id