NCT01461005终止不适用
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System(DSS)
Paradigm Spine2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2011年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure.
研究概览
简要总结
The purpose of the Post-Market Surveillance study is to evaluate safety.
详细描述
Paradigm Spine Dynamic Stabilization System (DSS) study is a prospective, multi-center, literature controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is skeletally mature (21-85 years old).
- •Patient has degenerative spondylolisthesis (Grade 1-3) with objective evidence of neurologic impairment, kyphosis, and/or failed previous fusion (pseudarthrosis) at index level.
- •Capable and willing to comply with the requirements unique to the study, adhere to the post-operative treatment and management program, and return for required follow-up examinations.
- •Surgeon has determined that DSS™ System is an appropriate treatment for the patient without regard to the study.
排除标准
- •The need for interbody cages, allograft, or any other assistance during surgery. Device is only to be used with autograft per FDA approved indications.
- •Any medical, mental or surgical condition precluding the potential benefit of spinal surgery or surgery in general.
- •Acute or chronic systemic, spinal or localized infections.
- •Active, severe systemic and metabolic diseases.
- •Obesity defined as Body Mass Index >
- •Subject is pregnant or interested in becoming pregnant in the next 36 months.
- •Dependency on pharmaceutical drugs, drug abuse, or alcoholism.
- •Lack of patient cooperation.
- •Foreign body sensitivity to the implant material.
- •Degenerative scoliosis greater than 25 degrees.
- •Grade 4 degenerative spondylolisthesis (>75% slip).
- •Significant osteopenia A screening questionnaire for osteopenia, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required*, exclusion will be defined as a DEXA bone density measured T score of ≤ -1.0 (The World Health Organization definition of osteopenia).
- •Soft tissue deficit not allowing wound closure.
- •Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device.
- •Inadequate pedicles or vertebral body geometry of the thoracic, lumbar and sacral vertebrae.
- •Bony lumbar spinal stenosis not related to the primary degenerative spondylolisthesis indication.
- •Pars defect.
- •Clinically compromised vertebral bodies at affected level due to current or past trauma.
- •Prisoner or ward of the state.
- •Currently in litigation regarding a spinal condition.
- •Known allergy to titanium, titanium alloys, CoCrMo, polyethylene or MR contrast agents.
- •Is currently involved in a study of another investigational product for similar purpose.
结局指标
主要结局
Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure.
时间窗: 6 months
The safety endpoint is defined as the incidence of serious or device related adverse events attributable to the device or procedure. Reoperations, revisions or removals of the Dynamic Stabilization System (DSS) System implant will be evaluated.
次要结局
- Measurement of Left Leg Pain as Assessed by Visual Analog Scale(6 months)
- Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI).(6 months)
- Measurement of Lower Back Pain as Assessed by Visual Analog Scale(6 months)
- Measurement of Right Leg Pain as Assessed by Visual Analog Scale(6 months)
- Number of Participants With Improved Health as Measured by the EuroQOL Health Related Qualify of Life- 5 Dimensions-3 Level (EQ-5D-3L) Health Questionnaire Compared to Baseline.(Pre-Op, 6 weeks, 6 months, 12 months, and 24 months)
研究者
研究点 (2)
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