Unilateral Versus Bilateral Vertebroplasty in Local Anaesthesia: A Prospective Randomised Comparative Study With 6-Month Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- Change in pain intensity (VAS score)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
排除标准
- •Active infection
- •Coagulopathy
- •Burst fracture with retropulsion
- •Neurological deficit
- •Malignancy-related fracture
结局指标
主要结局
Change in pain intensity (VAS score)
时间窗: 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)
时间窗: From baseline to 6 months post-procedure
Oswestry Disability Index score, range 0-100%, higher scores = greater disability.
Change in pain intensity (VAS score)
时间窗: 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)
时间窗: From baseline to 6 months post-procedure
Oswestry Disability Index score, range 0-100%, higher scores = greater disability.
次要结局
- 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))
- Complications(Intraoperative and 6 months post-procedure)
- 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))
- Complications(Intraoperative and 6 months post-procedure)
研究者
Igor Movrin
Professor of Surgery, University Medical Center Maribor
University Maribor