Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinical Investigation Centre for Innovative Technology Network | NETWORK |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early percutaneous vertebroplasty (EPV) | Experimental | Surgical procedure of percutaneous vertebroplasty. |
|
| Standard Conservative treatment (CT) | Active Comparator | Thoracolumbar corset. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early percutaneous vertebroplasty (EPV) | Device | Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mehdi Boudissa, MD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Grenoble | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22939104 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
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 |