Vertos Mild - Post Market Patient Outcomes
2013年2月22日 更新者：The Center for Pain Relief, Inc.
Single - Center, Prospective, Patient Outcomes Assessment of Minimally Invasive Lumbar Decompression With the Mild Devices in Patients With Symptomatic Central Canal Stenosis.
This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression.
The patients will be followed for 6 months after the procedure.
研究概览
详细说明
Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks.
Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management.
研究类型
介入性
注册 (实际的)
46
阶段
- 不适用
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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West Virginia
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Charleston、West Virginia、美国、25301
- The Center for Pain Relief, Inc
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Charleston、West Virginia、美国、25301
- The Center for Pain Relief, Inc.
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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
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy
- Prior failure of conservative therapy and Oswestry Disability Index (ODI) >20%
- Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically >2.5mm),confirmed by pre-op MRI/CT report
- Central canal cross sectional area clearly reduced per MRI/CT report
- If present, anterior listhesis < or = to 5.0mm (preferred) and deemed stable by the Investigator
- Able to walk at least 10 feet unaided before being limited by pain
- Available to complete 26 weeks of follow up
- A signed Consent Form is obtained from the patient
- Adults 18 years of age or older
Exclusion Criteria:
- Prior surgery at the intended treatment level
- Compound fracture with intraspinal retropulsion contributing to spinal stenosis
- Disabling back or leg pain from causes other than lumbar spinal stenosis
- Disc protrusion or osteophyte formation severe enough to confound study outcome
- Facet hypertrophy severe enough to confound study outcome
- Bleeding disorders and/or current use of anti-coagulants
- Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment
- Epidural steroids with 3 weeks prior to procedure
- Inability of patient to lie prone for any reason with anesthesia support
- Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the study outcomes
- Dementia and/or inability to give informed consent
- Pregnant and/or breastfeeding
- On workman's Compensation or considering litigation associated with back pain
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
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Minimally invasive lumbar decompression
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This minimally invasive procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine.
The patient is given local anesthesia and a sedative but needs to be responsive to the surgeon's questions for neurological monitoring.
Under image guidance, the mild tools are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process.
The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves.
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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 |
|---|---|---|
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Pain as Measured by Visual Analog Scale (VAS).
大体时间：Baseline and six months
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A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain.
The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.
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Baseline and six months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement in Functional Mobility
大体时间：baseline and month 6
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Measured subjectively by the Oswestry Disability Index.
Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity.
The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking.
Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations.
The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value.
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baseline and month 6
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Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).
大体时间：Baseline and month 6
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As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator.
A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms.
The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value.
Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity.
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Baseline and month 6
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Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).
大体时间：Baseline and month 6
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For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function.
Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6.
A positive value represents the baseline value minus the 6 month value.
Treatment is considered clinically relevant when at least a 0.5 improvement is achieved.
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Baseline and month 6
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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：Timothy R Deer, MD、Center for Pain Relief, Inc
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
2010年2月1日
初级完成 (实际的)
2012年1月1日
研究完成 (实际的)
2012年1月1日
研究注册日期
首次提交
2010年2月24日
首先提交符合 QC 标准的
2010年2月25日
首次发布 (估计)
2010年2月26日
研究记录更新
最后更新发布 (估计)
2013年4月2日
上次提交的符合 QC 标准的更新
2013年2月22日
最后验证
2013年2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.