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Completed

NCT Number: NCT07198776

Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Maribor, Department of Traumatology

Maribor, 2000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Age ≥65 years
  • Single-level painful osteoporotic vertebral compression fracture (OVCF) confirmed radiologically
  • Acute fracture (<6 weeks)
  • Failure of conservative therapy
  • Ability to provide written informed consentlusion Criteria:

Exclusion criteria

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

Treatment and study plan

percutaneous vertebroplasty

Procedure

Injection of PMMA cement into fractured vertebra under fluoroscopic guidance.

Primary outcomes

  1. Change in pain intensity (VAS score)

    Time frame: From baseline (preoperative) to 6 months post-procedure

    Pain intensity measured on a Visual Analogue Scale (0-10; higher scores = worse pain).

  2. Oswestry Disability Index (ODI)

    Time frame: From baseline to 6 months post-procedure

    Oswestry Disability Index score, range 0-100%, higher scores = greater disability.

Secondary outcomes

  1. Operative time

    Time frame: During procedure

    Duration of vertebroplasty procedure measured in minutes.

  2. Fluoroscopy time

    Time frame: During procedure

    Duration of fluoroscopic exposure during vertebroplasty, measured in seconds.

  3. Injected cement volume

    Time frame: During procedure

    Total volume of polymethylmethacrylate (PMMA) cement injected into the fractured vertebra, measured in milliliters.

  4. Vertebral height restoration

    Time frame: From baseline (preoperative) to hospital discharge (postoperative day 1)

    Percentage restoration of anterior vertebral body height on lateral radiographs.

  5. Kyphotic angle correction

    Time frame: From baseline (preoperative) to hospital discharge (postoperative day 1)

    Change in local kyphotic angle (°) on lateral radiographs.

  6. Complications

    Time frame: Intraoperative and 6 months post-procedure

    Incidence of perioperative and follow-up complications, including cement leakage, adjacent fractures, infection, or neurological events.

Sponsors and collaborators

Lead sponsor

Igor Movrin

Other

Registry information

Official study title

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

Acronym: UNI-BI PVP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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