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

NCT04273347 | Unknown

• 1 other identifier: APHP190623
• Study Type: observational
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries; Injury, Brain, Traumatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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,

  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

  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,

  12 months

• a clinical-biological risk score for Neurogenic Paraosteoarthropathies within 9 months of the trauma

  9 months

Study Arms (2)

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

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

Interventions

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

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

patient with brain trauma; patient with spinal cord injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Related Publications (2)

• 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.

  PMID: 29093266 RESULT

• 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.

  PMID: 24583537 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Brain Injuries, Traumatic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Brain Diseases; Craniocerebral Trauma

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Majorie Salga, MD

  Hôpital Raymond Poincaré

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjorie salga, MD

CONTACT

+33 1 47 10 70 82; marjorie.salga@aphp.fr

François Genet, Professor

CONTACT

+331 47 10 70 70; francois.genet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: February 18, 2020
• Study Start: September 15, 2023
• Primary Completion: November 15, 2024
• Study Completion: December 15, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share