SternaLock 360 First in Man Study: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sternal Bone Healing
研究概览
简要总结
The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system. The cerclage material serves to facilitate sternal approximation, and the plates and screws serve to provide rigid fixation and prevent sternal movement and separation. The combination of a cerclage material in combination with plate and screw fixation may also lead to increased stability compared to either method used as a standalone means of closure.
详细描述
The purpose of this study is to evaluate a new technology for sternal closure that combines rigid plate fixation with a cerclage material in patients undergoing a cardiac surgery subsequent to a full median sternotomy. This study will evaluate intraoperative outcomes related to the surgical technique and performance of the device, sternal healing and stability, sternal wound complications and postoperative recovery (e.g. pain and functional status) in patients closed with this device. For comparative purposes, a control group of wire cerclage patients will be included.
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)
盲法说明
participants are blinded to treatment choice until completion of the study.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a standard midline sternotomy as a result of a cardiac surgical procedure (i.e. coronary artery bypass graft (CABG) and/or valve replacement along with other cardiac surgical procedures)
- •Patients ≥ 30 years of age
- •Patients who sign the Informed Consent
排除标准
- •Pre-Operative
- •Patients with endstage renal failure who are on dialysis or post transplant patients
- •Patients taking chronic (>30 days) pre-operative narcotics
- •Patients taking chronic (>30 days) steroids, immunosuppressant (including biologic immunosuppressants such as Enbrel), or chemotherapeutics (e.g. methotrexate). Patients using a steroid inhaler for asthma should not be excluded.
- •Patients with confirmed HIV with a viral load of >10,000 copies
- •Patients with an active infection that is currently being treated
- •Patients with history or confirmed metal allergy or foreign body sensitivity
- •Patients with a previous partial or full midline sternotomy
- •Patients with previous radiation treatment of the chest
- •Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure: i.e., patients with cardiac disease resulting in inability to carry on any physical activity without discomfort (CCS ; NYHA)
- •Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia (STS)
- •Patients unwilling or unable to return for follow-up
- •Exclusion Criteria: Operative
- •Patients requiring delayed sternotomy closure
- •Patients with transverse sternal fractures located beneath the cerclage band on the SternaLock 360 Device.
- •Patients presenting intra-operative conditions that in the opinion of the treating surgeon would require or preclude a specific method for sternal closure, or who are not able to be closed per the protocol.
- •Use of non resorbable (beeswax) bonewax along the sternotomy
研究组 & 干预措施
SternaLock 360
Sternal closure performed with SternaLock 360 as a primary closure system
干预措施: SternaLock 360 (Device)
Wire Cerclage
Sternal closure performed with standard wire cerclage as a primary closure system
干预措施: Wire Cerclage (Device)
结局指标
主要结局
Sternal Bone Healing
时间窗: 6 months
Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively
次要结局
- Sternal Pain(Baseline, postoperative day 3 to day 7, 1-month post-op, 3-month post-op and 6-month post-op)
- Analgesic usage(Baseline, postoperative day 0 to day 7, 1-month post-op, 3-month post-op and 6-month post-op)
- Upper Extremities Functional Status(Baseline, 1-month post-op, 3-month post-op and 6-month post-op)
- Return to Work(Baseline, 1-month post-op, 3-month post-op and 6-month post-op)