Prospective Randomised Sternal Closure Study Sternalock 360 Plates vs Conventional Stainless Steel Wires
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Sternal motion
研究概览
简要总结
Design:
Investigator Initiated Prospective Randomised Trial
Study Centre's:
Melbourne Private Hospital Royal Melbourne Hospital
Study Hypothesis:
Use of the SternaLock 360 will reduce the incidence of sternal motion > 2mm by absolute difference of 40% at 6 weeks of surgery compared to stainless steel wiring.
Use of the SternaLock 360 will improve bone healing and quality of recovery after surgery compared to stainless steel wiring
Study Objective:
To determine if the SternaLock 360 system reduces sternal instability, increases bone healing, and improves quality of recovery compared to stainless steel wiring of the sternum, after cardiac surgery involving median sternotomy
Inclusion Criteria:
Age ≥ 18 year old Elective cardiac surgery Primary cardiac surgical procedure No evidence of infection at time of surgery Sufficient English language to complete the Postoperative Quality of Recovery Survey
Exclusion Criteria:
Previous sternotomy (redo) Clinical sternal deformity Home locality preventing follow-up (e.g. remote regional, interstate or overseas patient)
Number of Planned Subjects:
50
详细描述
Introduction/Background Information Since the inception of cardiac surgery in the early 1960s, division of the sternum has provided the superior access to cardiac structures. Cardiac surgery may involve treatment of the coronary arteries, valves or major vessels such as the ascending aorta. In children, correction of congenital malformations is also performed.
The conventional bone fixation during the 1960s was the placement of stainless steel wires around or through the sternum, predominantly as single wires which were tensioned by twisting. In the 1980s, it became fashionable for some cardiac surgeons to pass the wire twice around the bone (as would be the case repairing a fence on a farm), so-called "figure of 8" configuration and tensioning again occurring by twisting the wires. There have been no adequate studies investigating which of these two techniques may be superior.
In simple terms, bone healing is promoted by
- Minimising movement of the bone edges at the fracture site and
- Improved alignment of the bone edges
The sternum is a connecting bone that moves in multiple planes to transfer load and position the limbs in space during every day functional tasks and respond to the demands of respiration. The healing of the sternum is in the context of many efforts by the treating physicians and physiotherapists to encourage activities that might cause distracting forces at the sternal fracture site. Additionally, simple everyday activities by the patient such as coughing, deep breathing, sneezing, transferring in and out of bed, turning over in bed and driving all lead to substantial distracting forces acting on the sternal fracture site1. External fixation is not encouraged because the patient needs to have significant chest wall movement in order to breathe and clear sputum as part of the recovery from surgery.
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
- 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
- •Age ≥ 18 year old Elective cardiac surgery Primary cardiac surgical procedure No evidence of infection at time of surgery Sufficient English language to complete the Postoperative Quality of Recovery Survey
排除标准
- •Previous sternotomy (redo) Clinical sternal deformity Home locality preventing follow-up (e.g. remote regional, interstate or overseas patient)
研究组 & 干预措施
Sternalock 360 sternal plating system
use of the SternaLock 360 system to close the sternum: 3 plates with 3 bands and measured screw length to engage but not penetrate the posterior sternal cortex, used to close the sternum
干预措施: Sternalock 360 sternal plating system (Device)
Sternal wires
Stainless steel sternal wires applied in a "figure of 8" configuration to close the sternum
干预措施: Sternal Wires (Device)
结局指标
主要结局
Sternal motion
时间窗: 6 weeks after surgery
Sternal edge movement with coughing that is \>2 mm in any location as measured by ultrasound (US)
次要结局
- PostopQRS(1 day to 3 months)
- Penetration of the posterior cortical bone by screws(6-10 days after surgery)
- Sternal override(1 day to 3 months)
- Sternal motion(1 day to 3 months)
- MACCE(1 day to 3 months)
- Sternal pain(1 day to 3 months)
- Lung ultrasound(1 day to 3 months)
- Sternal wound infection(1 day to 3 months)
- FDQ(1 day to 3 months)
- Sternal closure time(1 day to 3 months)
- Degree of bone healing(3 months)
研究者
Colin Royse
Co-PI
University of Melbourne
