Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures. Monocentric, Prospective, Randomised and Compared Clinical Study

Conditions
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Vertebral Fracture

Intervention / Treatment
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* Device: Early percutaneous vertebroplasty (EPV)
* Device: Standard Conservative treatment (CT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early percutaneous vertebroplasty (EPV)<br>Surgical procedure of percutaneous vertebroplasty. | Device: Early percutaneous vertebroplasty (EPV)<br>* Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia.<br>|
| Active Comparator: Standard Conservative treatment (CT)<br>Thoracolumbar corset. | Device: Standard Conservative treatment (CT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Diagnosis, and after 3 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | 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 | Evaluation of the quality of cement filling as poor / acceptable / satisfactory, according to the method described in L.Garnier and col, 2012. | Immediately post-op | 
| Tolerability of the treatment by corset (CT arm) assessed using the number of thoracolumbar corset readjustments during treatment | Number of thoracolumbar corset readjustments carried out during follow up (3 months) | 3 months | 
| Evaluation of the observance of the treatment by corset (CT arm) | Daily observance report of thoracolumbar corset wear during follow up (3 months) | 3 months | 
| Comparison of the adverse events during the study between the two groups | Numbers of adverse events (classification : minor, mild, severe) | 3 months | 
| Comparison of physical performance evolution between 24h and 3 months after treatment, between the two groups | Physical performance will be assessed using Short Physical Performance Battery test (SPPB, score from 0 to 12) | 24 hours and 3 months after treatment | 
| Comparison of the evolution in the autonomy of the patients using ADL questionnaire (before and after vertebral fracture, and 3 months after treatment), between the two groups | ADL (Activities of Daily living) questionnaire score | Diagnosis (before / after fracture), and 3 months after treatment | 
| Comparison of the evolution in the autonomy of the patients using IADL questionnaire (before and after vertebral fracture, and 3 months after treatment), between the two groups | IADL (Instrumental ADL) questionnaire score | Diagnosis (before / after fracture), and 3 months after treatment | 
| Comparison of the evolution of quality of life using SF-36 questionnaire score (before and after vertebral fracture, and 3 months after treatment) between the two groups | SF-36 (Short Form-36 Health Survey) questionnaire score | Diagnosis (before / after fracture), and 3 months after treatment | 
| Comparison of the evolution of quality of life using QUALEFFO questionnaire (before and after vertebral fracture, and 3 months after treatment) between the two groups | QUALEFFO (Quality of life questionnaire of the European Foundation for Osteoporosis) questionnaire score | Diagnosis (before / after fracture), and 3 months after treatment | 
| Comparison of the number of days of hospitalization between the two groups | Length of hospitalization (days) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertebral fracture, Early Percutaneous Vertebroplasty, Standard Conservative Treatment, Kyphosis angle