Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
2016年10月3日 更新者：Rachiotek LLC
Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001
The intent of this study is to complete the collection of clinical data on subjects enrolled in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the now defunct Applied Spine Technologies Inc .
The Applied Spine assets, including the clinical trial data, were acquired by Rachiotek, LLC in 2010.
When Applied Spine ceased their funding of the trial, a number of enrolled patients had not yet completed the two year follow-up visit defined as the study endpoint in the clinical investigation plan.
No additional patient treatment is required to complete the study.
Rachiotek has interest in pursuing IDE approval for a new study and the information collected in this study is essential for supporting the new Investigational Device Exemption application.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
43
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
-
-
North Carolina
-
Durham、North Carolina、美国、27704
- Triangle Orthopedics
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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
21年 及以上 (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
非概率样本
研究人群
Community sample
描述
Inclusion Criteria:
- Any patient that after having met all of the inclusion/exclusion criteria identified for the Stabilimax Investigational Device Exemption study had enrolled in the Stabilimax Investigational Device Exemption study and were implanted with the Stabilimax NZ or the control device.
Exclusion Criteria:
- Any patient that has had the device removed and the adverse event follow-up report stated that the event was resolved. This applies only if the patient was formally withdrawn from the study at that time.
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 |
|---|
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Investigational Stabilimax
|
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Control, Posterolateral Fusion
|
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 |
|---|---|---|
|
Visual Analog Scale (VAS) for Leg Pain
大体时间：Minimum 24 months post procedure
|
Patient demonstrates a reduction in leg pain from baseline of at least 20 mm on a 100 mm visual analog scale (VAS)
|
Minimum 24 months post procedure
|
|
Zurich Claudication Questionnaire (ZCQ)
大体时间：Minimum 24 months post procedure
|
Clinically significant improvement from baseline defined by a minimum decrease of .5 as measured by the Zurich Claudication Questionnaire for both Symptom Severity(SS) and Physical Function (PF) scores
|
Minimum 24 months post procedure
|
|
Major Device Related (MDR) Complications
大体时间：Minimum 24 months post procedure
|
Patient experiences no major device-related complications
|
Minimum 24 months post procedure
|
|
Revision, Reoperation, or Removal
大体时间：Minimum 24 months post procedure
|
The treated level did not require surgical revision, reoperation, removal, or supplemental fixation.
|
Minimum 24 months post procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Oswestry Disability Index (ODI)
大体时间：Minimum 24 months post procedure
|
Changes from baseline in function scores (Oswestry Disability Index)
|
Minimum 24 months post procedure
|
|
Presence (control) or Absence (Stabilimax)of fusion
大体时间：Minimum 24 months post procedure
|
Presence (control patients) or absence (Stabilimax NZ® patients) of fusion at 24-months post procedure
|
Minimum 24 months post procedure
|
|
Adverse Events (AE)
大体时间：Minimum 24 months post procedure
|
safety will be assessed by quantification of the incidence of all adverse events observed during the study period by type.
|
Minimum 24 months post procedure
|
|
Physician Satisfaction Scale
大体时间：Immediately post procedure
|
Characterization of the physician's satisfaction with clinical implantation of the therapeutic device by use of rating scales.
|
Immediately post procedure
|
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。
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
2011年8月1日
初级完成 (实际的)
2012年11月1日
研究完成 (实际的)
2012年12月1日
研究注册日期
首次提交
2011年9月29日
首先提交符合 QC 标准的
2011年12月1日
首次发布 (估计)
2011年12月5日
研究记录更新
最后更新发布 (估计)
2016年10月4日
上次提交的符合 QC 标准的更新
2016年10月3日
最后验证
2016年10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.