Osteoporotic Vertebral Compression Fracture
Conditions
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.
Interventions
PROCEDUREPercutaneous Vertebroplasty
Injection of PMMA cement into fractured vertebra under fluoroscopic guidance.
Sponsors
Igor Movrin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Operative time | During procedure | Duration of vertebroplasty procedure measured in minutes. |
| Complications | Intraoperative and 6 months post-procedure | Incidence of perioperative and follow-up complications, including cement leakage, adjacent fractures, infection, or neurological events. |
| Kyphotic angle correction | From baseline (preoperative) to hospital discharge (postoperative day 1) | Change in local kyphotic angle (°) on lateral radiographs. |
| Fluoroscopy time | During procedure | Duration of fluoroscopic exposure during vertebroplasty, measured in seconds. |
Countries
Slovenia
Outcome results
None listed