Value of 3D Modeling in Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Questionnaire Showing the 3D Imaging Helped Surgery Planning
研究概览
简要总结
Adults (18 years and over) and children (10-17 years of age) scheduled for surgery to correct scoliosis will be included in this study, for which participation will last 6 months. Each age group of participants will be randomized to two cohorts: one cohort will receive standard of care, while the other will also have their standard radiographic images used in the construction of a three-dimensional visualization of the spine. Questionnaires administered before and after surgery, in addition to health information collected throughout the course of the study, will indicate whether the three-dimensional model has an effect on the planning, performance, and outcomes of surgery. Participants in this study will not be asked to do anything outside the standard of care. The only manipulated variable in this study is the construction of the three dimensional model, which is made from information collected during the standard of care, and requires no further action on the participant's behalf. The results of this study may show that three-dimensional visualizations can be of value to spinal surgeons, and positively affect patient outcomes.
详细描述
The biplanar low-dose EOS system and its associated spineEOS workstation (EOS®, EOS Imaging, Paris, France) allows 3D spine reconstructions. The EOS system presents some advantages over MRI or CT Scans. The weight bearing position allows assessment in the functional position and the radiation exposure is 800-1000 times less then CT scans, allowing full spine acquisition even in pediatric patients. Selected anatomical landmarks are utilized to reconstruct a 3D model of the spine allowing global assessment as well as localized analysis.The aim of the study is to assess the clinical relevance of 3D stereographic reconstructions (from spineEOS 3D) on patients, adults and children, who undergo spine surgery. This study will observe the value of 3D parameters at three different steps of the standard of care surgical procedure: preoperatively, peri-operatively, and post-operatively. The goal of this prospective study is to observe how 3D reconstructions could enhance the planning, the surgery and the post-op analysis and outcomes. This pilot study could help to understand which and how 3D parameters could improve adult and pediatric spine surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must be age 18 or greater at the time of surgery or initial consultation
- •Having a primary surgery of their spine (fusion or instrumentation)
排除标准
- •Diagnosis of scoliosis other than degenerative or idiopathic (i.e., paralytic/neuromuscular, congenital)
- •Undergoing revision (fusion or instrumentation)
- •EOS Exclusion Criteria:
- •Patients with supernumerary vertebrae (one extra or one less thoracic or lumbar vertebrae)
- •Insufficient quality of images to perform the 3D modeling with spineEOS software
- •Children --
- •Inclusion Criteria:
- •All patients must be younger than 18 at the time of surgery
- •Having a primary surgery of their spine (fusion or instrumentation)
- •Exclusion Criteria:
- •Diagnosis of scoliosis other than degenerative or idiopathic (i.e., paralytic/neuromuscular, congenital
- •Undergoing revision (fusion or instrumentation)
- •EOS Exclusion Criteria:
- •Patients with supernumerary vertebrae (one extra or one less thoracic or lumbar vertebrae)
- •Insufficient quality of images to perform the 3D modeling with spineEOS software
结局指标
主要结局
Questionnaire Showing the 3D Imaging Helped Surgery Planning
时间窗: 1 week post-operatively
The surgeon will complete a one-question surgical questionnaire regarding their perceptions of the value of 3D modeling brought to the care of their patient. "Did the 3D imaging help with planning the surgery?" Yes = it helped. No = it did not help.
次要结局
- Health Related Quality Of Life (HRQOL) Score(3-4 months post-op)
研究者
Lawrence Lenke
Professor of Orthopedic Surgery at the Columbia University Medical Center
Columbia University