NCT03252691撤回不适用
Study to Determine Incidence of Large Annular Defects And Measurement of Volume of Nucleus Removed in Primary Discectomy Patients
Intrinsic Therapeutics1 个研究点 分布在 1 个国家开始时间: 2020年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Incidence of large defects noted on primary lumbar discectomy procedure.
研究概览
简要总结
Lumbar discectomy study, collection and evaluation of incidence of large annular defects.
详细描述
This study is designed as a single-site prospective data collection. Measurements will be collected during 150 consecutive standard of care primary lumbar discectomy procedures.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18-75 years of age, and skeletally mature
- •Must have clinical and radiological evidence of primary lumbar disc herniation at one level of the lumbar spine between L3-S
- •Must be psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up care.
- •Subject must understand and sign the written Informed Consent.
排除标准
- •Prior surgery at the index lumbar vertebral level.
- •Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain
- •Morbid obesity (BMI ≥ 40 kg/m2)
- •Investigational drug or device use within 30 days
结局指标
主要结局
Incidence of large defects noted on primary lumbar discectomy procedure.
时间窗: Intra-operatively
Annular defect size will be measured intra-operatively.
次要结局
- Quantify the amount of nuclear disc material removed during primary lumbar discectomy procedure.(Intra-operatively)
- Verify access to annular defect with approved manual surgical instruments.(Intra-operatively)
研究者
研究点 (1)
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