Kyphoplasty With Structured Titanium Spheres: Pilot Study. P.R.O.B.E. Trial (Prospective Randomized Open Blinded End Point)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of prototype device usage, as assessed by Change from baseline in post-surgical complication rate at 1 month.
研究概览
简要总结
The aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification).
详细描述
Randomized controlled open trial with P.R.O.B.E. design (Prospective Randomized Open, Blinded End-point)
Objective:
The aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification).
All consecutive eligible patients, belonging to the Neurosurgery Unit of A.R.N.A.S. Civico Hospital, in Palermo, will be included in the pilot study: 10 patients will be recruited for the treatment arm and 10 patients for the control arm.
- Patients aged between 18 and 80 years.
- Diagnosis of vertebral body fracture, type A (according to Magerl classification) in particular A.1, A.2 and A.3.1.
- Absence of ligamentous structures lesion and / or invasion of the spinal canal, confirmed by RX TC and NMR.
- Refusal to sign informed consent,
- Diagnosis different from those established by inclusion criteria.
- Age under 18 years.
- Age over 80 years.
- Presence of ligamentous structures lesion and / or invasion of the spinal canal confirmed by RX, TC and NMR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Magerl Type A Thoracolumbar fracture with no neurological deficits
- •Age>18yy and < 80yy
- •No ligament lesions
排除标准
- •age < 18yy or > 80yy
- •Ligament lesions
- •refusal to sign informed consent
结局指标
主要结局
Feasibility of prototype device usage, as assessed by Change from baseline in post-surgical complication rate at 1 month.
时间窗: 1 month post operative control
Demonstrate if the prototype device is useful.
次要结局
- Pre, Post operation Vertebra height and changing in time(immediate, follow-up at 1-3-6 months after trauma)
- Ostheogenesis(6 months after trauma)
- Acquired kyphosis(6 months after trauma)
- Visual analogical Scale (VAS) and changing in time.(immediate, follow-up at 1-3-6 months after trauma)
研究者
Gabriele Costantino
Principal Investigator
ARNAS Civico Di Cristina Benfratelli Hospital