NCT01293981终止不适用
Radiographic and Clinical Outcomes of PureGen Osteoprogenitor Cell Allograft in Posterior Lumbar and Transforaminal Interbody Fusion Procedures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Fusion
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.
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
- •Subjects with back and/or leg pain electing to receive Transforaminal Lumbar Interbody Fusion (TLIF)/ Posterior Lumbar Interbody Fusion (PLIF) procedure and posterior transpedicular stabilization with or without decompression at any level
- •Unresponsive to conservative treatment for at least 6 months
- •Radiographic confirmation of primary diagnosis
排除标准
- •More than 2 levels requiring lumbar interbody fusion
- •Spondylolisthesis greater than Grade I
- •Prior failed fusion surgery at any lumbar level(s)
- •Local or systemic infection past or present
- •Active systemic disease
- •Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
- •BMI greater than 40
- •Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified
- •Use of post operative Spinal Cord Stimulator (SCS)
- •Any condition requiring postoperative medications that inhibit fusion, such as chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs
- •Known or suspected history of alcohol and/or drug abuse
- •Involved in pending litigation or worker's compensation related to the spine
- •Pregnant or plans to become pregnant during the course of the study
- •Insulin-dependent diabetes mellitus
- •Known sensitivity to device materials
- •Life expectancy less than duration of study
- •Any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires
- •Undergoing chemotherapy or radiation treatment
- •Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)
结局指标
主要结局
Fusion
时间窗: 24 months
Proportion of subjects with fusion at the 24 month visit
次要结局
未报告次要终点
研究者
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