NCT07198776

Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia

Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia: A Prospective Randomised Comparative Study With 6-Month Follow-Up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Igor Movrin · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Osteoporotic Vertebral Compression Fracture

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Vertebroplasty	Injection of PMMA cement into fractured vertebra under fluoroscopic guidance.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: Slovenia