Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures

University Hospital, Grenoble42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Vertebral Fracture

Interventions

Early percutaneous vertebroplasty (EPV)DEVICE

Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia.

Standard Conservative treatment (CT)DEVICE

Treatment consists of using a made-to-measure 3 point thoracolumbar corset,that is worn for 3 months: night and day during the first 6 week period of the treatment, and then only the day for the next 6 week period.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital, Grenoble

Grenoble, France

Outcomes

Primary Outcomes

Vertebral kyphosis change between fracture diagnosis and after 3 months of treatment, in the two groups

Difference in the kyphotic angle measured at the fracture diagnosis and after 3 months of treatment

Time frame: Diagnosis, and after 3 months of treatment

Secondary Outcomes

Compare the pain evolution between fracture diagnosis and after 3 months of treatment, in the two groups

Pain will be assessed using a Visual Analogic Scale (score from 0 to 10)

Time frame: diagnosis, after 24 hours, 45 days and 3 months of treatment

Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Kyphotic Angle

Kyphotic angle (KA)

Time frame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment

Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Anterior vertebral height

Anterior vertebral height (HA)

Time frame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment

Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Vertebral Compression Ratio

Vertebral Compression Ratio (AP)

Time frame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment

Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Regional kyphotic angle

Regional kyphotic angle (RA)

Time frame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment

Quality of the early vertebroplasty procedure (EPV arm) assessed as the quality of cement filling

Data from ClinicalTrials.gov

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