Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
2022年3月7日 更新者：Philips Clinical & Medical Affairs Global
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries).
The objective of the study was to investigate the accuracy of screw placement during spine surgery.
研究概览
研究类型
观察性的
注册 (实际的)
21
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Stockholm、瑞典
- Karolinska University Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients > 16 years.
描述
Inclusion Criteria:
- Subject undergoing a spine surgery with pedicle screw placement
- Subject 16 years of age or older
- Subject able to give informed consent
Exclusion Criteria:
- Subject participating in a potentially confounding device or drug trial during the course of the study.
- Subject meeting an exclusion criteria according to national law (e.g. pregnant woman, breast feeding woman)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
New image-guidance software
Patients in this group had spine surgery with new image-guidance software application.
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Patients in this group had spine surgery with new image-guidance software application
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software
大体时间：During surgery, mean 6.71 hours
|
Clinical accuracy of pedicle screw placements using new image-guidance software assessed by three independent reviewers. Accuracy grading was done per Gertzbein classification. Gertzbein classification: grade 0 = breach 0 mm, grade 1 = breach < 2 mm, grade 2 = breach 2-4 mm, grade 3 = breach > 4 mm. Values in the data table represent the percentage of screw placements that were determined accurate by three independent reviewers. |
During surgery, mean 6.71 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Procedure Time
大体时间：During surgery, mean 6.71 hours
|
Time from skin incision to skin closure
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During surgery, mean 6.71 hours
|
|
Time to Insert Pedicle Screw
大体时间：Intraoperative, mean 5.18 hours
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Intraoperative, mean 5.18 hours
|
|
|
Length of Hospitalization
大体时间：From start of the interventional procedure until hospital discharge, approximately 5.3 days
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From start of the interventional procedure until hospital discharge, approximately 5.3 days
|
|
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System Usability Score (SUS Score)
大体时间：End of all surgeries
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The SUS is a validated standard questionnaire to evaluate the system usability.
Score varies between 0 and 100 (0 meaning the lowest usability score, 100 meaning highest usability score).
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End of all surgeries
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Patient Radiation Dose
大体时间：During surgery, mean 6.71 hours
|
Radiation dose measured in Air Kerma (AK)
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During surgery, mean 6.71 hours
|
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Patient Radiation Dose
大体时间：During surgery, mean 6.71 hours
|
Radiation dose measured in Dose Area Product (DAP)
|
During surgery, mean 6.71 hours
|
|
Radiation Dose (Effective Dose) Received by Operator
大体时间：During surgery, mean 6.71 hours
|
During surgery, mean 6.71 hours
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|
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Procedure Related Complications
大体时间：During surgery, mean 6.71 hours
|
Complication is leading to invasive intervention (e.g.
blood sample, invasive intervention, IV/IM medication).
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During surgery, mean 6.71 hours
|
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Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event
大体时间：From start of enrollment until hospital discharge, approximately 51 days
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From start of enrollment until hospital discharge, approximately 51 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Adrian Elmi-Terander, MD、Karolinska University Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年11月9日
初级完成 (实际的)
2017年10月8日
研究完成 (实际的)
2017年10月8日
研究注册日期
首次提交
2017年1月2日
首先提交符合 QC 标准的
2017年1月5日
首次发布 (估计)
2017年1月9日
研究记录更新
最后更新发布 (实际的)
2022年3月8日
上次提交的符合 QC 标准的更新
2022年3月7日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.