Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures (AGIL11)

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Vertebral Fracture

Treatments

Device: Early percutaneous vertebroplasty (EPV)

Device: Standard Conservative treatment (CT)

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT03617094

38RC17.276

Details and patient eligibility

About

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.

Full description

In this study, 58 patients with a vertebral fracture no more than 10 days old (with a max of 15 days old) will be enrolled. Treatment will be randomly allocated in 2 groups: Early percutaneous vertebroplasty (EPV group) or standard conservative treatment (corset, CT group). Patients will be followed up during 3 months after treatment. They will receive standard care for a vertebral fracture at the Grenoble-Alpes University Hospital.

Evaluated criteria: Vertebral kyphosis evolution, Pain, Efficacy and Quality of vertebroplasty procedure, Tolerance and observance of the standard treatment, Safety, Physical performance, Quality of life, Autonomy.

Enrollment

42 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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