Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients refuse randomization.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral height, volume and cyphotic angle between the two techniques, as well as extravation of ciment and functional and quality of life aspects related to these techniques.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kyphoplasty | Experimental | Patients randomized to this arm will be treated via balloon kyphoplasty. |
|
| Vertebroplasty | Active Comparator | Patients randomized to this arm will be treated via vertebroplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kyphoplasty | Procedure | Patients will be treated via a balloon kyphoplasty surgical procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| The volume (cm^3) of injected ciment | The volume of injected ciment is measured by catscan extrapolated data. | Baseline (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of vertebral volume (%) | Recovery of vertebral volume relative to theoretical volume based on neighboring vertebra. | Day 1 to Day 7 |
| Change from baseline of the cyphotic angle (°) | The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pascal Kouyoumdjian, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
Not provided
| ID | Term |
|---|---|
| D058498 | Kyphoplasty |
| D054854 | Vertebroplasty |
| ID | Term |
|---|---|
| D060826 | Cementoplasty |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vertebroplasty | Procedure | Patients will be treated via a transcutaneous vertebroplasty procedure. |
|
| Days 1 to 7 |
| Change from baseline of the cyphotic angle (°) | The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°) | 1 month |
| Change from baseline of the cyphotic angle (°) | The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°) | 3 months |
| Change from baseline in vertebral height (mm) | Change in vertebra height (mm) before and after surgery | Days 1 to 7 |
| Change from baseline in vertebral height (mm) | Change in vertebra height (mm) before and after surgery | 1 month |
| Change from baseline in vertebral height (mm) | Change in vertebra height (mm) before and after surgery | 3 months |
| Volume of ciment leakage (cm^3) | The volume of ciment leakage will be determined according to catscan data. | Day 1 |
| Change in Visual Analog Scale (0 to 10) for pain before and after surgery | Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery | Day 0 (post-op) |
| Change in Visual Analog Scale (0 to 10) for pain before and after surgery | Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery | 1 month |
| Change in Visual Analog Scale (0 to 10) for pain before and after surgery | Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery | 3 months |
| % Change in Visual Analog Scale (0 to 10) for pain before and after surgery | The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery | Day 0 (post-op) |
| % Change in Visual Analog Scale (0 to 10) for pain before and after surgery | The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery | 1 month |
| % Change in Visual Analog Scale (0 to 10) for pain before and after surgery | The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery | 3 months |
| The change in the ODI score before and after surgery | The change in the Oswestry Disability Index before and after surgery | 3 months |
| The % change in the ODI score before and after surgery | The percentage change (%) in the Oswestry Disability Index before and after surgery | 3 months |
| Change in SF-36 quality of life score before and after surgery | Change in SF-36 quality of life score before and after surgery | 1 month |
| Change in SF-36 quality of life score before and after surgery | Change in SF-36 quality of life score before and after surgery | 3 months |
| The % change in SF-36 quality of life score before and after surgery | Percentage change (%) in SF-36 quality of life score before and after surgery | 1 month |
| The % change in SF-36 quality of life score before and after surgery | Percentage change (%) in SF-36 quality of life score before and after surgery | 3 months |
| Change in FABQ score before and after surgery | Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery | 1 month |
| Change in FABQ score before and after surgery | Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery | 3 months |
| % Change in FABQ score before and after surgery | Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery | 1 month |
| % Change in FABQ score before and after surgery | Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery | 3 months |
| Change in DPQ score before and after surgery | Change in the Dallas Pain Questionnaire score before and after surgery | 1 month |
| Change in DPQ score before and after surgery | Change in the Dallas Pain Questionnaire score before and after surgery | 3 months |
| % Change in DPQ score before and after surgery | Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery | 3 months |
| % Change in DPQ score before and after surgery | Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery | 1 month |
| Duration of surgery (minutes) | Length of operative time (minutes) | Day 0 (day of surgery) |
| Presence / absence of per-operative complications | Presence / absence of per-operative complications | Day 0 (day of surgery) |
| Presence / absence of post-operative complications | Presence / absence of post-operative complications | 1 month |
| Presence / absence of post-operative complications | Presence / absence of post-operative complications | 3 months |