Clinical trial NCT03617094: Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures
Official title: Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures. Monocentric, Prospective, Randomised and Compared Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertebral Fracture
Keywords: Vertebral fracture
Early Percutaneous Vertebroplasty
Standard Conservative Treatment
Kyphosis angle
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2018-08-06
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Vertebral kyphosis change between fracture diagnosis and after 3 months of treatment, in the two groups
timeFrame: Diagnosis, and after 3 months of treatment
Secondary outcomes:
measure: Compare the pain evolution between fracture diagnosis and after 3 months of treatment, in the two groups
timeFrame: diagnosis, after 24 hours, 45 days and 3 months of treatment
measure: Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Kyphotic Angle
timeFrame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
measure: Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Anterior vertebral height
timeFrame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
measure: Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Vertebral Compression Ratio
timeFrame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
measure: Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Regional kyphotic angle
timeFrame: Diagnosis, immediat post-op, after 45 days and 3 months of treatment
measure: Quality of the early vertebroplasty procedure (EPV arm) assessed as the quality of cement filling
timeFrame: Immediately post-op
measure: Tolerability of the treatment by corset (CT arm) assessed using the number of thoracolumbar corset readjustments during treatment
timeFrame: 3 months
measure: Evaluation of the observance of the treatment by corset (CT arm)
timeFrame: 3 months
measure: Comparison of the adverse events during the study between the two groups
timeFrame: 3 months
measure: Comparison of physical performance evolution between 24h and 3 months after treatment, between the two groups
timeFrame: 24 hours and 3 months after treatment
measure: 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
timeFrame: Diagnosis (before / after fracture), and 3 months after treatment
measure: 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
timeFrame: Diagnosis (before / after fracture), and 3 months after treatment
measure: 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
timeFrame: Diagnosis (before / after fracture), and 3 months after treatment
measure: 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
timeFrame: Diagnosis (before / after fracture), and 3 months after treatment
measure: Comparison of the number of days of hospitalization between the two groups
timeFrame: 3 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital, Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Mehdi Boudissa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garnier L, Tonetti J, Bodin A, Vouaillat H, Merloz P, Assaker R, Court C; French Society for Spine Surgery. Kyphoplasty versus vertebroplasty in osteoporotic thoracolumbar spine fractures. Short-term retrospective review of a multicentre cohort of 127 consecutive patients. Orthop Traumatol Surg Res. 2012 Oct;98(6 Suppl):S112-9. doi: 10.1016/j.otsr.2012.03.018. Epub 2012 Aug 28.