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Spinal Cord InjuriesBENTHOSNCT04273347

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

An observational study of Spinal Cord Injuries and Injury, Brain, Traumatic, run by Assistance Publique - Hôpitaux de Paris.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
118 participants
Where
No sites listed yet
Study dates
15 Sep 2023to 15 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

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

About this study

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"

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.

Read the 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.

Being tested
standard of care for patient with brain trauma and spinal cord injury
Medical subject headings
Spinal Cord Injuries, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard of care for patient with brain trauma and spinal cord injuryOther

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

Study groups in NCT04273347
Study groupRoleWhat they receive
patient with brain traumaall patient with brain trauma in intensive care unit
Receives: Other: standard of care for patient with brain trauma and spinal cord injury
patient with spinal cord injuryall patient with spinal cord injury in intensive care unit
Receives: Other: standard of care for patient with brain trauma and spinal cord injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Neurogenic Paraosteoarthropathies

    Determine the incidence of Neurogenic Paraosteoarthropathies within 9 months of a brain trauma and/or spinal cord injury

    Measured: 9 months

Secondary outcomes (6)

  1. 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

    Measured: 9 months

  2. 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,

    Measured: 9 months

  3. 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

    Measured: 15 days

  4. 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,

    Measured: 12 months

  5. 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

    Measured: 9 months

  6. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2020
  2. Study start15 Sep 2023 (estimated)
  3. Primary completion15 Nov 2024 (estimated)
  4. Study completion15 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04273347
Sponsor's protocol ID
APHP190623
Acronym
BENTHOS
Status last verified
Aug 2023
First submitted
22 Nov 2019
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 29093266

  • 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.

    PubMed 24583537

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Injuries and Injury, Brain, Traumatic, run by Assistance Publique - Hôpitaux de Paris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marjorie salga, MD (+33 1 47 10 70 82, marjorie.salga@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Neurogenic Paraosteoarthropathies (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04273347, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

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BENTHOS Clinical Trial NCT04273347 | AzTrials