Incidence of Neurogenic Paraosteoarthropathies in a Population of Brain

Status Not yet recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04273347
Study type	Observational
Source	Assistance Publique - Hôpitaux de Paris
Contact	Marjorie salga, MD
Phone	+33 1 47 10 70 82
Email	marjorie.salga@aphp.fr
Status	Not yet recruiting
Phase
Start date	September 15, 2023
Completion date	December 15, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms