NCT02058238撤回不适用
ADDRESS - Multicenter, Partially-randomized Controlled Trial of Adult Deformity Robotic vs. Freehand Surgery to Correct Adult Spine Deformity
Mazor Robotics1 个研究点 分布在 1 个国家开始时间: 2014年10月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Intraoperative radiation exposure
研究概览
简要总结
To quantify potential short- and long-term benefits of robotically-guided minimally invasive (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a matching cohort of control patients, performed using a freehand technique, both in MIS and open approaches.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
- •Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis.
- •Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).
- •Patient capable of complying with study requirements
- •Signed informed consent by patient
排除标准
- •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
- •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
Intraoperative radiation exposure
时间窗: Day of operation
as measured by the C-arm, normalized per screw
Revision surgeries
时间窗: 2 years
All cause revisions, including medical and surgical complications.
Incidence of surgical complications
时间窗: 1 year
New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss
次要结局
- Ratio of executed vs. planned screws(Day of surgery)
- Times of intra-operative stages(Day of surgery)
- Fusion rate/pseudoarthrosis(Within one year post-surgery)
- Deformity correction as measured on plain radiographs(Within 2 years from surgery)
- Clinical outcome measures assessed using health-related quality of life questionnaires(up to 10 years post-operative)
- Implant Failure(Within 1 year post-surgery)
- Neuromonitoring events(Day of surgery)
- Number of Abandoned Screws(Day of surgery)
- Pedicle screw instrumentation accuracy(Within 1 year of surgery)
- Length of convalescence(Within 2 years of surgery)
- Number of screws instrumented freehand(Day of surgery)
- Clinical performance of instrumentation technique(Day of surgery)
研究者
研究点 (1)
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