NCT00292292终止不适用
Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage
SpinalMotion41 个研究点 分布在 1 个国家目标入组 514 人开始时间: 2005年1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
- 514
- 试验地点
- 41
- 主要终点
- Improvement in Oswestry Low Back Pain Disability Score at 24 months compared with baseline; no revision removal, supplemental fixation or device related reoperations and no major adverse event as defined by the study protocol
研究概览
简要总结
The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single level degenerative disc disease at L4/5 or L5/S1.
详细描述
The Kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in 3 foot print sizes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 18 and 60 years of age
- •Have evidence of degenerative disc disease (DDD)
- •History of back and/or radicular pain which is severe, ongoing and recurrent
- •Minimum 6 month period of prior conservative care
- •Moderate Oswestry Disability Index score
- •Moderate pain score
- •Be likely to return for all follow-up visits
- •Be willing and able to provide Informed Consent for study participation.
排除标准
- •Any back or leg pain of unknown origin
- •Foot drop
- •Previous trauma to the study treatment level with compression or bursting
- •Previous retroperitoneal surgery
- •Other spinal surgery at affected level except IDET, laminotomy
- •Previous thoracic or lumbar fusion
- •Documented abnormal abdominal vessel or muscular/fascial pathology or morphology
- •Degenerative spondylolisthesis
- •Ischemic (spondylolytic) spondylolisthesis
- •Spondylitis
- •Documented significant spinal, foraminal or lateral stenosis
- •Severely reduced disc space height
- •Documented presence of free nuclear fragment
- •Extensive facet arthritis or degeneration of the facets at any level noted on MRI, CT or X-ray
- •Scoliosis of the lumbar spine
- •Metabolic bone disease
- •Active systemic infection
- •Hepatitis
- •Active malignancy or history of metastatic malignancy
- •Any terminal or autoimmune disease
- •Any other disease, condition or surgery which might impair healing
- •Recent history of chemical or alcohol dependence
- •Current or extended use of any drug known to interfere with bone or soft tissue healing
- •Known metal allergy
- •Morbid obesity
- •Transitional vertebrae at level to be treated that has not clearly fused
- •Currently a prisoner
- •Currently involved in spinal litigation
- •Currently experiencing an episode of major mental illness
- •Pregnancy at time of enrollment, since this would contraindicate abdominal surgery
- •Participation in another drug, diologic or medical trial within 30 days of study surgery
- •Lives more than 300 miles from a study center or participation in any other investigational drug, biologic or medical device study.
结局指标
主要结局
Improvement in Oswestry Low Back Pain Disability Score at 24 months compared with baseline; no revision removal, supplemental fixation or device related reoperations and no major adverse event as defined by the study protocol
时间窗: 24 months
次要结局
- Maintenance or improvement in neurologic status(24 months)
- Pain improvement(24 months)
- Significant disc height increase(24 months)
- No displacement or migration of the device(24 months)
- Time to return to work(24 months)
- Time to recovery(24 months)
- Preservation of at least 4 degrees of motion in flexion/extension(24 months)
研究者
研究点 (41)
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