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Osteoporotic vertebral compression fractures are a common cause of severe back pain and disability in elderly patients. Percutaneous vertebroplasty (PVP) with polymethylmethacrylate (PMMA) cement is widely used to relieve pain and stabilize the fractured vertebra. However, there is ongoing debate whether unilateral or bilateral vertebroplasty provides better clinical and radiological outcomes. This prospective randomized controlled trial was conducted at the University Medical Center Maribor to compare unilateral versus bilateral PVP performed under local anaesthesia. A total of 196 patients with acute osteoporotic vertebral compression fractures were enrolled and randomly assigned to one of the two groups. The primary outcome measure was pain reduction assessed by Visual Analogue Scale (VAS). Secondary outcomes included functional improvement measured by the Oswestry Disability Index (ODI), procedure duration, fluoroscopy time, injected cement volume, radiological changes (vertebral height, kyphotic angle), and perioperative complications. The results are expected to provide evidence to guide optimal surgical management of osteoporotic vertebral fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral Vertebroplasty | Experimental | Patients undergo percutaneous unilateral vertebroplasty with polymethylmethacrylate (PMMA) cement under local anaesthesia. |
|
| Bilateral Vertebroplasty | Active Comparator | Patients undergo percutaneous bilateral vertebroplasty with polymethylmethacrylate (PMMA) cement under local anaesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Vertebroplasty | Procedure | Injection of PMMA cement into fractured vertebra under fluoroscopic guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity (VAS score) | Pain intensity measured on a Visual Analogue Scale (0-10; higher scores = worse pain). | From baseline (preoperative) to 6 months post-procedure |
| Oswestry Disability Index (ODI) | Oswestry Disability Index score, range 0-100%, higher scores = greater disability. | From baseline to 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Duration of vertebroplasty procedure measured in minutes. | During procedure |
| Fluoroscopy time | Duration of fluoroscopic exposure during vertebroplasty, measured in seconds. |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Maribor, Department of Traumatology | Maribor | 2000 | Slovenia |
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| During procedure |
| Injected cement volume | Total volume of polymethylmethacrylate (PMMA) cement injected into the fractured vertebra, measured in milliliters. | During procedure |
| Vertebral height restoration | Percentage restoration of anterior vertebral body height on lateral radiographs. | From baseline (preoperative) to hospital discharge (postoperative day 1) |
| Kyphotic angle correction | Change in local kyphotic angle (°) on lateral radiographs. | From baseline (preoperative) to hospital discharge (postoperative day 1) |
| Complications | Incidence of perioperative and follow-up complications, including cement leakage, adjacent fractures, infection, or neurological events. | Intraoperative and 6 months post-procedure |