Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia (UNI-BI PVP)

Igor Movrin

Status: Completed

Conditions: Osteoporotic Vertebral Compression Fracture

Treatments: Procedure: Percutaneous Vertebroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT07198776

National Medical Ethics Commit

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Unilateral Vertebroplasty

Experimental group

Description:

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

Treatment:

Procedure: Percutaneous Vertebroplasty

Bilateral Vertebroplasty

Active Comparator group

Description:

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

Treatment:

Procedure: Percutaneous Vertebroplasty