Vertebral Fracture
Conditions
Keywords
Vertebral fracture, Early Percutaneous Vertebroplasty, Standard Conservative Treatment, Kyphosis angle
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.
Interventions
DEVICEEarly percutaneous vertebroplasty (EPV)
Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia.
DEVICEStandard Conservative treatment (CT)
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.
Sponsors
Clinical Investigation Centre for Innovative Technology Network
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vertebral kyphosis change between fracture diagnosis and after 3 months of treatment, in the two groups | Diagnosis, and after 3 months of treatment | Difference in the kyphotic angle measured at the fracture diagnosis and after 3 months of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Kyphotic Angle | Diagnosis, immediat post-op, after 45 days and 3 months of treatment | Kyphotic angle (KA) |
| Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Anterior vertebral height | Diagnosis, immediat post-op, after 45 days and 3 months of treatment | Anterior vertebral height (HA) |
| Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Vertebral Compression Ratio | Diagnosis, immediat post-op, after 45 days and 3 months of treatment | Vertebral Compression Ratio (AP) |
| Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Regional kyphotic angle | Diagnosis, immediat post-op, after 45 days and 3 months of treatment | Regional kyphotic angle (RA) |
| Quality of the early vertebroplasty procedure (EPV arm) assessed as the quality of cement filling | Immediately post-op | Evaluation of the quality of cement filling as poor / acceptable / satisfactory, according to the method described in L.Garnier and col, 2012. |
| Tolerability of the treatment by corset (CT arm) assessed using the number of thoracolumbar corset readjustments during treatment | 3 months | Number of thoracolumbar corset readjustments carried out during follow up (3 months) |
| Evaluation of the observance of the treatment by corset (CT arm) | 3 months | Daily observance report of thoracolumbar corset wear during follow up (3 months) |
| Compare the pain evolution between fracture diagnosis and after 3 months of treatment, in the two groups | diagnosis, after 24 hours, 45 days and 3 months of treatment | Pain will be assessed using a Visual Analogic Scale (score from 0 to 10) |
| Comparison of physical performance evolution between 24h and 3 months after treatment, between the two groups | 24 hours and 3 months after treatment | Physical performance will be assessed using Short Physical Performance Battery test (SPPB, score from 0 to 12) |
| 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 | Diagnosis (before / after fracture), and 3 months after treatment | ADL (Activities of Daily living) questionnaire score |
| 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 | Diagnosis (before / after fracture), and 3 months after treatment | IADL (Instrumental ADL) questionnaire score |
| 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 | Diagnosis (before / after fracture), and 3 months after treatment | SF-36 (Short Form-36 Health Survey) questionnaire score |
| 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 | Diagnosis (before / after fracture), and 3 months after treatment | QUALEFFO (Quality of life questionnaire of the European Foundation for Osteoporosis) questionnaire score |
| Comparison of the number of days of hospitalization between the two groups | 3 months | Length of hospitalization (days) |
| Comparison of the adverse events during the study between the two groups | 3 months | Numbers of adverse events (classification : minor, mild, severe) |
Countries
France
Outcome results
None listed