NCT01643395已完成3 期
VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2010年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Disability scale
研究概览
简要总结
The purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering from acute non osteoporotic vertebral compression fracture.
Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse.
Our study will compare vertebroplasty versus conservative therapy (brace).
详细描述
The study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (VCF) type A according Magerl classification
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 70 year old
- •volunteers
- •Vertebral compression fractures Magerl type A
- •Acute Trauma (less than 15 days)
- •Between T5 and L5
- •Patient able to undergo both vertebroplasty and conservative treatment
- •Consent form obtained
排除标准
- •Neural arch fracture
- •C1 to T4 fracture
- •Neurologic symptoms caused by the fracture
- •Encephalic trauma with Glasgow Coma Scale less than 15
- •Ongoing cancer
- •Routine painkillers intake
- •Local or systemic infection
- •Coagulation's disorder
- •Pregnancy
- •Involvement in an another clinical trial
研究组 & 干预措施
conservative therapy (brace)
Other
干预措施: conservative therapy (Other)
vertebroplasty
Experimental
干预措施: vertebroplasty (Other)
结局指标
主要结局
Disability scale
时间窗: at 1 month
次要结局
- Spine radiological measurements(at 1, 3 and 6 months)
- Disability and qol(at 3 and 6 months)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral FractureNCT06776003Spine Centre of Southern Denmark64
已完成
不适用
A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic FracturesVertebral Compression FracturesOsteoporotic Vertebral Compression FracturesAcute Vertebral FracturesNCT01482793Optimus Clinical Research120
已完成
不适用
Percutaneous Vertebroplasty Versus Conservative Treatment of PainPainOsteoporosisFractureNCT00203554University of Aarhus27
已完成
3 期
Vertebroplasty for the Treatment of Fractures Due to OsteoporosisSpinal FracturesOsteoporosisNCT00068822Mayo Clinic131
Unknown
不适用
A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by OsteoporosisSpinal FracturesNCT00290862Orthovita d/b/a Stryker256