Incidence of Neurogenic Paraosteoarthropathies in a Population of Brain Traumatized and Spinal Co… (NCT04273347) | Clinical Trial Compass
UnknownNot Applicable
Incidence of Neurogenic Paraosteoarthropathies in a Population of Brain Traumatized and Spinal Cord Injured Patients and Specific Markers of Early NPOA Development"
118 participantsStarted 2023-09-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.