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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries; Injury, Brain, Traumatic
• Intervention / Treatment: Other: standard of care for patient with brain trauma and spinal cord injury

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.

• Study Type: Observational
• Enrollment (Estimated): 118

Contacts and Locations

• Study Contact: Name: Marjorie salga, MD; Phone Number: +33 1 47 10 70 82; Email: marjorie.salga@aphp.fr
• Study Contact Backup: Name: François Genet, Professor; Phone Number: +331 47 10 70 70; Email: francois.genet@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patient with brainTrauma or spinal cord injury upon arrival in intensive care

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient with brain trauma; all patient with brain trauma in intensive care unit	Other: standard of care for patient with brain trauma and spinal cord injury; 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	Other: standard of care for patient with brain trauma and spinal cord injury; neurological examination, examination of articulation, infectious status, respiratory status, inflammatory status,kinesitherapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Majorie Salga, MD, Hôpital Raymond Poincaré

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2023
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Spinal Cord Injuries
• Other Study ID Numbers: APHP190623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No