Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia

Not Applicable

Completed

• Conditions: Osteoporotic Vertebral Compression Fracture

• Registration Number: NCT07198776
• Lead Sponsor: Igor Movrin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30
• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-21
• Last Update Submitted: 2025-09-21
• Study First Posted: 2025-09-30
• Last Update Posted: 2025-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Not provided

Exclusion Criteria

• Active infection
• Coagulopathy
• Burst fracture with retropulsion
• Neurological deficit
• Malignancy-related fracture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in pain intensity (VAS score)	From baseline (preoperative) to 6 months post-procedure	Pain intensity measured on a Visual Analogue Scale (0-10; higher scores = worse pain).
Oswestry Disability Index (ODI)	From baseline to 6 months post-procedure	Oswestry Disability Index score, range 0-100%, higher scores = greater disability.

Secondary Outcome Measures

Name	Time	Method
Operative time	During procedure	Duration of vertebroplasty procedure measured in minutes.
Fluoroscopy time	During procedure	Duration of fluoroscopic exposure during vertebroplasty, measured in seconds.
Injected cement volume	During procedure	Total volume of polymethylmethacrylate (PMMA) cement injected into the fractured vertebra, measured in milliliters.
Vertebral height restoration	From baseline (preoperative) to hospital discharge (postoperative day 1)	Percentage restoration of anterior vertebral body height on lateral radiographs.
Kyphotic angle correction	From baseline (preoperative) to hospital discharge (postoperative day 1)	Change in local kyphotic angle (°) on lateral radiographs.
Complications	Intraoperative and 6 months post-procedure	Incidence of perioperative and follow-up complications, including cement leakage, adjacent fractures, infection, or neurological events.

Trial Locations

Locations (1)

University Medical Center Maribor, Department of Traumatology; 🇸🇮 Maribor, Slovenia