NCT04629807进行中（未招募）不适用
The Anterior Gen Plus Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Assessment of fusion for the DBM versus CBM cohorts
研究概览
简要总结
A clinical study evaluating patients treated with the Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM) in anterior lumbar interbody fusion.
详细描述
A prospective, single-center, clinical study evaluating patients undergoing primary, contiguous 2-level ALIF without supplemental fixation treated with Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM).
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
- None
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
- •≥18 years of age
- •Requires anterior lumbar interbody (ALIF) fusion
- •Are physically and mentally able and willing to return for the scheduled follow up visits, follow post-operative instructions
- •Willing and able to sign study specific Informed Consent Form
排除标准
- •Signs of acute infection
- •Active malignancy and/or current chemotherapy
- •Prior fusion at operative or adjacent level
- •Institutionalized or a prisoner
- •Documented history of alcohol or drug abuse
- •Undergoing a worker's compensation case
- •Pregnancy
- •Participation in another research study involving another implant or drug that may affect the outcomes of this clinical study
- •Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study
结局指标
主要结局
Assessment of fusion for the DBM versus CBM cohorts
时间窗: 12 months
Proportion of levels exhibiting fusion for the DBM cohort versus the CBM cohort
次要结局
- Serious Adverse Events (SAEs)(24 Months)
研究者
研究点 (2)
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