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

Spinal Cord Injuries Clinical Trial

— BENTHOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04273347
• Other study ID #: APHP190623
• Status: Not yet recruiting
• Start date: September 15, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marjorie salga, MD
• Phone: +33 1 47 10 70 82
• Email: marjorie.salga[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: December 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Injury, Brain, Traumatic
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

References & Publications (2)

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 Muscu — View Citation

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 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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