Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebr… (NCT03617094) | Clinical Trial Compass
CompletedNot Applicable
Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures
France42 participantsStarted 2018-07-05
Plain-language summary
The aim of this study is to evaluate the efficacy of carrying out early vertebroplasty procedure, compared to the standard conservative treatment (corset), in order to prevent residual deformations that could occur in complications of vertebral fractures that are medically treated using a corset.
This is a monocentric, randomized, parallel group, prospective and open-label study.
Who can participate
Age range
50 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:
* 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
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.
What they're measuring
1
Vertebral kyphosis change between fracture diagnosis and after 3 months of treatment, in the two groups
Timeframe: Diagnosis, and after 3 months of treatment