Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Blood loss within the first 24 hours after posterior spinal fusion
研究概览
简要总结
The aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion.
详细描述
After being informed about the study and potential risks, all patients giving written inform consent will be included in the study during their preoperative visit. After eligibility criteria checking and based on their respective surgical indication, participants will be randomized in a single-blinded and stratified manner (participant only) in a 1:1 ratio to ARISTA-AH or no ARISTA-AH. The stratification process will consider the number of instrumented vertebra during each surgery (level 1: 5 to 8 vertebra; level 2: 9 or more instrumented vertebra).
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
- Single (Participant)
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
- •Patient eligible to a posterior lumbar or thoraco-lumbar long-segment spinal fusion.
- •Surgery targeting at least 5 adjacent vertebra combined with one of the following procedure:
- •Intersomatic bone graft;
- •Pedicle substraction osteotomy;
- •Any other intervertebral osteotomy (e.g. Smith-Petersen osteotomy);
- •The use of a surgical drain inserted at the operative site is mandatory (suction drain and other drain are eligible);
排除标准
- •Subject under the age of 18 years old;
- •Subject with a known haemostatic disorder;
- •Subject with any infection or any immune system disorder;
- •Subject not eligible to a posterior spinal surgery;
- •Subject with a known allergy or any contraindication to the use of the study device;
- •Currently pregnant or planning pregnancy;
- •Prisoner or a ward of the state;
- •Subject no willing to participate in the study;
- •Subject not affiliated to a social security insurance.
研究组 & 干预措施
ARISTA
ARISTA-AH will be applied directly within the wound before closure.
干预措施: ARISTA (Device)
Control group
Participant will not receive the ARISTA-AH hemostatic agent.
干预措施: Control Group (Device)
结局指标
主要结局
Blood loss within the first 24 hours after posterior spinal fusion
时间窗: 24 hours
Blood loss calculated in ml per number of instrumented vertebra
次要结局
- Blood loss within the first 48 hours after posterior spinal fusion(48 hours)
- Total post-operative blood loss(3 Days)
- Improvement of back and leg pains at 3 months compared to preoperative scores(3 months)
- Drain removal(7 Days)
- Estimated Blodd Loss (EBL)(7 Days)
- Hidden Blood Loss (HBL)(7 Days)
- Change in Patient's quality of life(3 months)
- Blood loss within the first 6 hours after posterior spinal fusion(6 hours)
- Incidence of any serious adverse events(3 Months)
- Detection of any early post-operative haematoma(7 Days)
- Assessment of the Oswestry Disability Index(3 months)
- Length of stay(7 Days)
- Detection of any haemostasis disorder(3 Months)