Sternal Fixation With STERN FIX After Medial Sternotomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sternal stability
研究概览
简要总结
The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use.
The main goal of this registry is to evaluate the sternal stability in patients who had their sternum fixed with the STERN FIX system.
Participants will have their sternotomy closed with the STERN FIX device at the end of their cardiothoracic surgery and will be followed up as per standard of care. At discharge and at the 1 month FU visit the sternal stability will be assessed using the sternal instability scale (SIS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Older than 18 years old patient
- •Patient undergoing surgery requiring medial sternotomy
- •Patient able and willing to provide informed consent to participate in the registry and/or who have provided written consent to have their clinical data added to the registry
排除标准
- •Patients that are still growing.
- •Patients with Sternal anomalies preventing the use of the STERN FIX Sternal Stabilization System, such as bone tumors located in the implant region.
- •Patient with conditions previous to surgery that may impact healing, including bone blood supply limitations, insufficient quantity or quality of bone, or other severe structural bone damage.
- •Patients with suspected or known allergies or intolerances to the implant material.
- •Patients with severe osteoporosis or other degenerative bone diseases.
- •Any patient unwilling to, or incapable of, following postoperative care instructions.
- •Patients with any other medical or surgical process that may compromise or limit the adequate functionality of the implant.
- •Pregnant patients or planning to become pregnant during the 2 months following surgery.
- •Patients with life expectancy lower than 2 months.
- •Patients who are or have been participating in an interventionist trial during the last 4 weeks
- •Intraoperative exclusion criteria
- •Latent or active infection, or inflammation in the operating area.
- •Signs of infection on the surgical site.
- •Parasternal sternotomy.
- •When the STERN FIX Sternal Stabilization System cannot ensure sufficient fixation.
- •When a STERN FIX Sternal Stabilization System device cannot be placed properly in any intercostal space.
结局指标
主要结局
Sternal stability
时间窗: One month postoperatively
The primary outcome for this registry will be the sternal stability assessed with the sternal instability scale (SIS). The SIS is a scale ranging from 0 to 3 with the following descriptors: * 0\. Clinically stable sternum (no detectable motion) - normal * 1\. Minimally separated sternum (slight increase in motion upon special testing\* - upper limbs, trunk) * 2\. Partially separated sternum - regional (moderate increase in motion upon special testing\*) * 3\. Completely separated sternum - entire length (marked increase in motion upon special testing\*)
次要结局
- Prevalence and type of AE and SAE(Through study completion, an average of 6 months)
- Prevalence of device deficiencies.(Through study completion, an average of 6 months)
- Sternal closure time(Surgery)
- Easiness of implantation of the device (Likert)(Immediately after surgery)
- Easiness of implantation of the device (assistance)(Immediately after surgery)
- Surgeon satisfaction for the use of the device(Immediately after surgery)