CompletedNot Applicable

Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia

Slovenia196 participantsStarted 2022-01-01

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pain intensity (VAS score)

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

Oswestry Disability Index (ODI)

Timeframe: From baseline to 6 months post-procedure

Trial details

NCT IDNCT07198776

SponsorIgor Movrin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Osteoporotic Vertebral Compression Fracture trials