University Medical Center Maribor, Department of Traumatology
Maribor, 2000, Slovenia
NCT Number: NCT07198776
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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Notify Me65 year and older
All sexes
Interventional
Not applicable
Maribor, 2000, Slovenia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Exclusion criteria
Injection of PMMA cement into fractured vertebra under fluoroscopic guidance.
Time frame: From baseline (preoperative) to 6 months post-procedure
Pain intensity measured on a Visual Analogue Scale (0-10; higher scores = worse pain).
Time frame: From baseline to 6 months post-procedure
Oswestry Disability Index score, range 0-100%, higher scores = greater disability.
Time frame: During procedure
Duration of vertebroplasty procedure measured in minutes.
Time frame: During procedure
Duration of fluoroscopic exposure during vertebroplasty, measured in seconds.
Time frame: During procedure
Total volume of polymethylmethacrylate (PMMA) cement injected into the fractured vertebra, measured in milliliters.
Time frame: From baseline (preoperative) to hospital discharge (postoperative day 1)
Percentage restoration of anterior vertebral body height on lateral radiographs.
Time frame: From baseline (preoperative) to hospital discharge (postoperative day 1)
Change in local kyphotic angle (°) on lateral radiographs.
Time frame: Intraoperative and 6 months post-procedure
Incidence of perioperative and follow-up complications, including cement leakage, adjacent fractures, infection, or neurological events.
Igor Movrin
Other
Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia: A Prospective Randomised Comparative Study With 6-Month Follow-Up
Acronym: UNI-BI PVP
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