Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia

NCT07198776 | Completed

• 1 other identifier: National Medical Ethics Commit
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporotic Vertebral Compression Fracture

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Operative time

  During procedure

• Fluoroscopy time

  During procedure

• Injected cement volume

  During procedure

• Vertebral height restoration

  From baseline (preoperative) to hospital discharge (postoperative day 1)

• Kyphotic angle correction

  From baseline (preoperative) to hospital discharge (postoperative day 1)

Study Arms (2)

Unilateral Vertebroplasty

EXPERIMENTAL

Patients undergo percutaneous unilateral vertebroplasty with polymethylmethacrylate (PMMA) cement under local anaesthesia.

Procedure: Percutaneous Vertebroplasty

Bilateral Vertebroplasty

ACTIVE COMPARATOR

Patients undergo percutaneous bilateral vertebroplasty with polymethylmethacrylate (PMMA) cement under local anaesthesia.

Procedure: Percutaneous Vertebroplasty

Interventions

Percutaneous Vertebroplasty PROCEDURE

Injection of PMMA cement into fractured vertebra under fluoroscopic guidance.

Bilateral Vertebroplasty; Unilateral Vertebroplasty

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Igor Movrin: lead

Study Sites (1)

University Medical Center Maribor, Department of Traumatology

Maribor, 2000, Slovenia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery, University Medical Center Maribor

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 30, 2025
• Study Start: January 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)