NCT02084264终止不适用
Multicenter, Prospective, Partially Randomized, Controlled Trial of Robotic-guided vs. Freehand Corrective Surgery for Pediatric Scoliosis
Mazor Robotics4 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2014年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 272
- 试验地点
- 4
- 主要终点
- Revision surgeries
研究概览
简要总结
To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Pediatric/adolescent patients (age 10 to 21 years), undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater
- •Patient capable of complying with study requirements
- •Signed informed consent by patient
排除标准
- •Scheuermann's disease
- •Infection or malignancy
- •Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- •Primary muscle diseases, such as muscular dystrophy
- •Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
- •Spinal cord abnormalities with any neurologic symptoms or signs
- •Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- •Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
- •Patients requiring anterior release or instrumentation
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
- •Patient cannot follow study protocol, for any reason
- •Patient cannot or will not sign informed consent
结局指标
主要结局
Revision surgeries
时间窗: 1 year post-surgery
All cause revisions, including medical and surgical complications.
次要结局
- Clinical Outcomes as measured on plain radiographs(2 years)
- Ratio of executed vs. planned screws(Day of surgery)
- Surgical complications(Within first year from day of surgery)
- Pedicle screw instrumentation accuracy(Within 1 year of surgery, if indicated by surgeon and clinically necessary)
- Clinical performance of instrumentation technique(Day of surgery)
- Improvement of radiographic and health-related quality of life metrics(up to 10 years post-operative)
- Length of convalescence(within 2 years of surgery)
- Radiation Exposure(Day of surgery)
- Hypoplastic pedicles(Day of surgery)
- Neuromonitoring events(Day of surgery)
研究者
研究点 (4)
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