NCT04593732已完成不适用
Clinical Investigation to Evaluate the STERN FIX Device As a Sternal Fixation System in Medium Sternotomy
NEOS Surgery1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年12月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sternal stability according to clinical evaluation
研究概览
简要总结
Pre-market clinical research, prospective, single-arm that aims to assess the sternal sealing in patients in which the sternum has been fixed with the STERN FIX system.
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
- •Patient over 18 years old.
- •Patient who must have surgery in which a medium sternotomy is indicated.
- •Subjects able to give their voluntary informed consent to participate in clinical research and from which written consent has been obtained.
- •The subject is able to meet the requirements of the protocol and is willing to do so.
排除标准
- •Patient with suspicious or known allergies or intolerance to implant material (PEEK - polyetheretherketone).
- •Patient with limitations in blood supply, insufficient bone quantity or quality, severe osteoporosis, osteomalacia or other serious bone structural damage, which, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
- •Degenerative bone diseases.
- •Patients with a latent or active infection or inflammation in the operating area that, at the surgeon's discretion, may interfere with the implantation or proper functioning of the product.
- •Patients with fever or leukocytosis.
- •Patient with spinal abnormalities that, according to the surgeon's discretion, prevent the use of the product, such as bone tumors located in the implant region.
- •Patients who are pregnant or interested in becoming pregnant within 6 months of surgery.
- •Nursing patients.
- •Patients with life expectancy less than 6 months.
- •Patients who are participating in or participating in the previous 4 weeks in another interventional clinical study
结局指标
主要结局
Sternal stability according to clinical evaluation
时间窗: 1 month post-surgery
sternal instability scale (SIS) grade: from 0 (Clinically stable sternum ) to 3 Completely separated sternum
次要结局
- sternal stability according to clinical evaluation(7 days post-surgery, 6 months)
- Prevalence of patients with dehiscence (without infection)(6 months)
- Prevalence and causality of adverse events(6 months)
- Prevalence of device deficiencies(6 months)
- Prevalence of reinterventions(6 months)
- Prevalence of superficial and deep sternal wound infections(6 months)
- Prevalence of patients with compromised sternal integrity(6 months)
- Prevalence of artefacts associated with the product in medical images(6 months)
- Time to close the sternal (minutes)(surgery)
- Surgeon satisfaction score(immediately post-surgery)
- Chest Pain(pre-surgery, 7 days post-surgery, 1 month, 6 months)
- Upper limb functionality(pre-surgery, 7 days post-surgery, 1 month, 6 months)
- Quality of life measured with EuroQol-5D-5L(pre-surgery, 7 days post-surgery, 1 month, 6 months)
- Working status(pre-surgery, 6 months)
- Sternal healing grade according to CT results(6 months)
研究者
研究点 (1)
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