A Prospective Study of the Safety and Efficacy of InQu® Bone Graft Extender in Transforaminal and Posterior Lumbar Interbody Fusion Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Post-operative bone fusion as measured by lumbar CT scan Bone fusion
研究概览
简要总结
The purpose of this study is to collect on-label safety and efficacy data where InQu Bone Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).
It is expected that this study will contribute to the compilation of clinical data required to demonstrate the ability of InQu to promote safe, effective and timely spine fusion in patients who undergo PLIF or TLIF surgery. The results of this study will lead to further analysis (i.e. comparison to historical data of other marketed bone graft products, as well as, to local bone alone).
详细描述
The purpose of this study is to collect on-label safety and efficacy data where InQu Bone Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) at multiple clinical sites.
Adverse events, time to fusion and Patient Reported Outcomes(PROs) will be recorded through 12 months follow-up.
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
- •A subject may be included if s/he meets the following criteria:
- •≥18 years of age;
- •Able to give appropriate informed consent;
- •Willing and able to meet the proposed follow-up schedule;
- •Has documented diagnosis of up to, and including, Grade 1 spondylolisthesis and/or degenerative disc disease;
- •Has given appropriate consent for, and undergoes, standard-of-care transforminal or posterior lumber interbody fusion;
- •Use of InQu Bone Graft Extender on-label.
排除标准
- •Any prior lumbar fusion surgery;
- •Requires fusion surgery of more than two adjacent levels;
- •Has fusion surgery requiring titanium cages;
- •Has a systemic infection or has infection at the site of surgery;
- •Has a medical condition or requires post-operative medication that, in the opinion of the investigator, may interfere with bony/soft tissue healing;
- •Has any physical, social, psychological or economic condition that, in the opinion of the investigator, may preclude accurate data collection or evaluation.
结局指标
主要结局
Post-operative bone fusion as measured by lumbar CT scan Bone fusion
时间窗: 12 months
次要结局
- Need for subsequent surgical intervention at target and/or adjacent level(Continual post treatment)
- Adverse Events(Continual post treatment)