National, Multicentre, Pilot Study, to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System Indicated for Vertebral Compression Fracture Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hyprevention
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Difficulties of the procedure [feasibility of the procedure]
研究概览
简要总结
The purpose of this pilot study is to evaluate the safety and performance of the V-STRUT© Transpedicular Vertebral System for the treatment of vertebral compression fractures of the thoracic or lumbar spine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Unstable fractures or neoplasms with posterior involvement
- •Nonmobile fractures
- •Damages of the pedicles or posterior wall
- •Less than one third of the original vertebral body height remaining
- •Spinal canal stenosis (>20%)
- •Neurologic signs or symptoms related to the compression fracture or impeding pathological fracture
- •Patient clearly improving on conservative treatment
- •Pregnancy, breastfeeding
- •Any contra-indication / allergy to implant material or cement
- •Any previous surgical treatment (material or cement) in the targeted vertebra
- •Systemic infection or infection located in the spine
- •Any medical condition including but not limited to anaemia, coagulation disorders, fibromyalgia, algoneurodystrophy, Paget's disease, uncontrolled diabetes that would preclude the patient from having surgery or would impede the benefit of surgery
- •Patient under the age of majority
结局指标
主要结局
Difficulties of the procedure [feasibility of the procedure]
时间窗: per-operative
Record difficulties experienced by surgeons during the procedure: each individual step of the procedure will be recorded and quoted by practitioners as very easy, easy, difficult or very difficult.
Cement quantity injected [feasibility of the procedure]
时间窗: per-operative
Record cement quantity injected in the vertebral body, in cc (cubic centimeter).
Operating time [feasibility of the procedure]
时间窗: per-operative
Measuring the duration of the surgical procedures.
Hospitalisation stay [feasibility of the procedure]
时间窗: per-operative and immediate post-op
Measuring the duration of the hospitalisation stay.
Type of anaesthesia [feasibility of the procedure]
时间窗: per-operative
Record the type of anaesthesia as GA (General Anaesthesia), local anaesthesia + sedation, or other.
次要结局
- Rates of cement leakage [safety of the device](Per-operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Pain [performance of the device](pre- operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Functional score [safety of the device](per-operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Rates of fractures [safety of the device](Per-operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Frequencies of ADEs and SADEs [safety of the device](per- operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Haematomas and infections rates [safety of the device](per-operative, immediate post-op, at 2 months, 6 months and 12 months.)
- Wound healing [safety of the device](per-operative, immediate post-op, at 2 months, 6 months and 12 months.)