Multi-center, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 9
- 主要终点
- Revision surgeries
研究概览
简要总结
To quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a minimally invasive approach whether freehand or with image guidance or navigation techniques.
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age over 21 years), undergoing short (4 or less consecutive vertebrae) lumbar or lumbosacral percutaneous/MIS spinal fixation surgery.
- •May include surgeries involving iliac screws, although these screws will not be included in the data analysis.
- •Primary fusion surgery
- •Patient capable of complying with study requirements
- •Signed informed consent by patient
排除标准
- •Revision surgery (prior laminectomy or discectomy is not excluded).
- •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
All cause revisions
Intra-operative exposure to x-ray radiation
时间窗: Day of surgery
Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room.
Surgical complications
时间窗: Within first year from day of surgery
New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse
次要结局
- Ratio of executed vs. planned screws(Day of surgery)
- Incidence of pseudoarthrosis (malunion)(Within 1 year from surgery)
- Length of convalescence(Within 1 year of surgery)
- Quality of life assessment(Each visit up to 1 year1)
- Pedicle screw instrumentation accuracy(Within 1 year of surgery, if indicated by surgeon and clinically necessary)
- Times of intra-operative stages(Day of surgery)