Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT03617094
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 50 years
* Fracture localisation : vertebrae from T8 to L5
* Recent fracture (\< 10 days, maximum 15 days)
* CT scan showing a fracture of the superior endplate and of the anterior cortex of the vertebral body of type A1 according to the Magerl classification AND vertebral kyphosis deformation \< 30°
* Patient affiliated to the French social security system or an equivalent system
* Patient who has signed consent form
Exclusion Criteria:
* Multiple level fracture
* Repeated fracture at the same level
* Others peripheral fractures
* Contraindication for percutaneous procedure
* Contraindication for vertebroplasty procedure (pathology with risk of decompensation, coagulation problems, deformation considered by the surgeon to be inaccessible by vertebroplasty procedure, presence of an infected site)
* Contraindication for anasthesia
* Methylmethacrylate (MMA) allergy known
* Impossibility to plan the start of the treatment (set up of treatment or carrying out of a vertebroplasty gesture) within a maximum deadline of 15 days after the fracture
* Body Mass Index (BMI) \> 31,5
* Progressive local infection
* Progressive local cancer
* Patient presenting cognitive disorder with behavioural disorder which could disturb the treatment
* Non-cooperative patient
* Patient who can not be followed up at Grenoble hospital during the 3 months of the study
* Patient concerned by articles L1121-5, L1121-6, L1121-8 of the French public health code
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03617094
Study Brief:
Protocol Section:
NCT03617094