NCT02064855终止不适用
The Fusion Rate With K2M VESUVIUS® Demineralized Fibers Used With K2M EVEREST® Spinal System Compared to Autologous Bone Graft With Posterior Stabilization
K2M, Inc.0 个研究点目标入组 108 人开始时间: 2014年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 108
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate fusion status and patient outcomes observed from use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the literature reported outcomes of spinal fusion using autograft with posterior stabilization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-cervical spinal stenosis; spondylolisthesis (grade 1 or 2); and/or degenerative disc disease (DDD) with one or two contiguous levels requiring surgical intervention between L1-S
- •Qualified patients will be confirmed for inclusion by patient history and radiographic studies
- •Willing and able to comply with the requirements of the protocol including follow-up requirements
- •Willing and able to sign a study specific informed consent
- •Skeletally mature and I 18 years old at time of enrollment
排除标准
- •Previous spine surgery at the index level
- •Previous posterior spine surgery (e.g., posterior decompression) that destabilizes the lumbar spine
- •Active systemic infection or infection at the operative site
- •Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
- •Metabolic bone disease such as osteoporosis and osteopenia that contradicts spinal surgery
- •History of an osteoporotic fracture
- •History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
- •Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
- •Known allergy to titanium or cobalt chrome
- •Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C, or fibromyalgia
- •Insulin-dependent type 1 or type 2 diabetes
- •Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
- •Pregnant, or intends to become pregnant, during the course of the study
- •Severe obesity (Body Mass Index > 40)
- •Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain, or quality of life.
- •Involved in current or pending spinal litigation where permanent disability benefits are being sought
- •Incarcerated at the time of study enrollment
- •Current participation in an investigational study that may impact study outcomes
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 24 months
All adverse events will be documented including device related, procedure related and additional serious adverse events.
Fusion Status on CT at 12 Months
时间窗: 12 months
Fusion is categorized as Partial consolidation and Bridging/Fusion. Partial consolidation is defined as consolidation of bone graft material with no complete bridging seen. Bridging/Fusion is defined as clear evidence of solid bridging bone between posterolateral gutters, facet joints and/or transverse processes.
次要结局
- Patient Satisfaction(12 months, 24 months)
- Length of Surgery Time(At time of surgery)
- Length of Anesthesia Time(At time of surgery)
- Radiographic Assessments(12 Months and 24 Months)
- Estimated Blood Loss(At time of surgery)
- Length of Hospital Stay(Admission to discharge)
- Use of Narcotics Post-surgery(Pre-Op to 24 months)
- Time to Return to Work/School(Pre-Op to 24 months)
- Change From Baseline in Quality of Life Scores on the SF-12v2 at 24 Months(Baseline (up to 8 weeks post-operatively) to 24 months)
- Change From Baseline in Daily Functional Ability Scores on the Oswestry Disability Index (ODI)(Baseline (Pre-Op), 24 months)
- Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months(Baseline (up to 8 weeks post-operatively) to 24 months)
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