NCT07366203尚未招募不适用
Clinical Investigation to Evaluate the Use of Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
NEOS Surgery0 个研究点目标入组 190 人开始时间: 2026年2月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 主要终点
- Sternal stability
研究概览
简要总结
The goal of this clinical trial is to learn if a new medical device (SC03 plates) to close the sternum after a sternotomy in patients that have been operated of a cardiac surgery, is safe and effective. The main question it aims to answer is:
Do patients that have the sternum closed with the SC03 plates present a stable sternum one month after surgery?
Researchers will compare the SC03 plates with stainless steel wires (current standard of care to close the sternum).
Participants will:
- be implanted with the SC03 or stainless steel wires.
- visit the clinic one month and six months after surgery
- Keep a diary of their symptoms and analgesia use
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 ≥ 18 years old.
- •Patient who must undergo surgery in which a median or an upper partial sternotomy is indicated.
- •Patients capable of giving their voluntary informed consent to participate in the clinical investigation and from whom written consent has been obtained.
- •Patient able and willing to meet the protocol requirements and to follow postoperative care instructions
排除标准
- •Patient with sternal anomalies, such as bone tumours located in the sternum.
- •Patient with limited sternum bone blood supply.
- •Patient with suspected or known allergies or intolerances to the implants materials: PEEK, carbon fibre, titanium, stainless steel.
- •Patient with severe osteoporosis or other degenerative bone diseases that affect the sternum.
- •Pregnant or breastfeeding patient or patient planning to become pregnant during the first 6 months after surgery.
- •Patient who is currently using opioid analgesics (e.g., morphine, oxycodone, hydrocodone, fentanyl, tramadol) for the management of chronic or acute pain.
- •Patient with diagnosis of dementia with a mental status score (MMSE) <
- •Patient with life expectancy lower than 6 months.
- •Patient with any other medical process that may compromise or limit the adequate functionality of the implants.
- •Patient involved in other interventionist clinical trial or that have been involved in other interventionist clinical trial during the previous 4 weeks.
- •Patient with signs of latent or active infection or inflammation on the surgical site.
- •Patient with insufficient quantity or quality of sternum bone, or other severe structural bone damage.
- •Patient for whom the closure technique cannot ensure sufficient sternal fixation.
- •Parasternal sternotomy.
- •Patient with intraoperative conditions that may compromise or limit the adequate functionality of the implants or that may prevent the surgeon to use the sternal closure system or that cannot be closed following the product instructions for use
研究组 & 干预措施
SC03 plates
Experimental
Adjustable carbon fiber sternal plates
干预措施: SC03 Plating system (Device)
Wires
Active Comparator
Stainless steel sternal wires
干预措施: Stainless steel wires (Device)
结局指标
主要结局
Sternal stability
时间窗: 1 month post operatively
Sternal stability measured by clinical assessment using the sternal instability scale (SIS), with grades 0 to 3 where 0 is "Clinically stable sternum" and 3 is "Completely separated sternum - entire length"
次要结局
- Safety of the SC03 Plating System(Perioperative, 1 month and 6 months postoperatively.)
- Reinterventions(1 month and 6 months postoperatively)
- Infections(First month and six months postoperatively.)
- Sternal dehiscence(First month and six months postoperatively)
- Sternotomy closure duration(Surgery)
- Easiness of use of the closure method(Surgery)
- Sternal Pain(Baseline, 7 days, 1 month and 6 months postoperatively.)
- Analgesia required(Day 7, 1 month and 6 months postoperatively)
- Post-surgery blood loss(12 hours postoperatively)
- Blood loss(48 hours after surgery)
- Blood loss(48 hour after surgery)
- Intensive Care Unit stay duration(from surgery date to Intensive care unit discharge date (up to 150 days)])
- hospitalization duration(from surgery date to hospital discharge date (up to 150 days))
- sternal stability(7 days and 6 months postoperatively)
- Upper Limb functional index(Before surgery, one month and 6 months postoperatively)
- Quality of life - EQ5D5L(Before surgery, one month and 6 months postoperatively)
- Chest bulging(1 month after surgery)
- Pulmonary function(Baseline, day 7 and 1 month postoperatively)
研究者
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