Perioperative Outcomes of Multilevel Posterior Spinal Fusion in Adolescent Scoliosis With Two Energy Dissection Techniques
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 64
- 试验地点
- 10
- 主要终点
- Estimated Intraoperative Blood Loss
研究概览
简要总结
The OSTEOVUE™ Spine Dissector is a new ultrasonic energy device, specifically designed for soft tissue removal from vertebral surfaces. The aim of the present study is to compare blood loss in multilevel PSF surgeries in patients with adolescent scoliosis (idiopathic or neuromuscular) done with ED or with UD. Blood loss will be estimated by major intraoperative surgical Stage (1 and 2) and postoperatively (until discharge). Additionally, the study will assess the possible influence of the device use in secondary perioperative outcomes.
详细描述
The primary objective is to compare intraoperative blood loss between surgeries performed with monopolar electrocautery and ultrasonic energy (as the primary means for soft tissue dissection) in patients diagnosed with adolescent scoliosis undergoing multilevel (>=6) posterior spinal fusion (PSF).
This is a prospective, multicenter, pair-matched comparison study that will be carried out in two phases:
Phase I Perioperative outcome variables (primary and secondary) will be collected from patients with adolescent scoliosis, meeting the study inclusion criteria, scheduled to undergo PSF using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces. This group will be the Electrocautery Dissection (ED) group.
Phase II The same outcomes variables measured on the ED group during Phase I will be subsequently collected from a group of patients with adolescent scoliosis, meeting the study inclusion criteria and scheduled to undergo PSF surgery. For this study group, surgery will be performed with the Harmonic OSTEOVUE™ Spine Soft Tissue Dissector (referred to as the OSTEOVUE™ Dissector in this protocol) and metal Cobb elevator, as the primary means of soft tissue dissection and removal from vertebral surfaces. This group will be the Ultrasonic Dissection (UD) group.
Patients in the UD group will be recruited from the existing patient population of PSF candidates at each participating site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 10 and 21 years of age;
- •Diagnosed with neuromuscular scoliosis associated with cerebral palsy or with idiopathic scoliosis between the ages of 10 and 18;
- •Indicated for primary PSF surgery;
- •Anticipated >= 6 vertebrae fusions;
- •Not in need of three column osteotomy (pedicle subtraction osteotomy [PSO]);
- •Not in need of vertebral column resection (VCR);
- •Curve magnitude >45 degrees for scoliosis and for sagittal deformity; and
- •An American Society of Anesthesiologists (ASA) physical status (PS) classification of 1 to 4
排除标准
- •One or both parents or a guardian unable or unwilling to provide parental permission and child assent (if capable, the child must express willingness to participate);
- •Previous failed vertebral fusion at same target levels;
- •Syndromic scoliosis;
- •Congenital scoliosis;
- •Early-onset scoliosis (onset before 10 years of age);
- •Requiring an anterior procedure;
- •Requiring PSO;
- •Requiring VCR;
- •Presence of coagulation abnormalities;
- •Planned staged procedure (exclude if second stage or beyond);
- •Requiring emergency surgery; and/or
- •Participation in any other clinical study (not to include registry or survey-only studies) for the duration of the study.
研究组 & 干预措施
Ultrasonic Dissection (UD)
Patients meeting the study criteria, scheduled to undergo PSF using ultrasonic dissection and metal Cobb elevator for soft tissue dissection and removal from vertebral surfaces.
干预措施: Ultrasonic Dissection (UD) (Device)
Electrocautery Dissection (ED)
Patients meeting the study criteria, scheduled to undergo posterior spinal fusion (PSF) using monopolar electrocautery and metal Cobb elevator (considered the current standard) for soft tissue dissection and removal from vertebral surfaces.
干预措施: Electrocautery Dissection (ED) (Device)
结局指标
主要结局
Estimated Intraoperative Blood Loss
时间窗: Intraoperative
Estimated blood loss during intraoperative Stage 1, defined as the period from first incision to the first bone violation/cut (e.g., first pedicle screw drill); and intraoperative Stage 2, defined as the period from first bone violation/cut to last suture.
次要结局
未报告次要终点