Clinical and Radiographic Outcomes of Transforaminal Lumbar Interbody Fusion (TLIF) With a Novel 3D Printed Cellular Titanium Implant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Radiographic Fusion
研究概览
简要总结
This study is designed to evaluate clinical outcomes and spine fusion rates for patients undergoing transforaminal lumbar interbody fusion using the CONDUIT 3D printed titanium TLIF cage.
详细描述
This prospective, single-center study is being conducted as a post market evaluation of the CONDUIT 3D printed titanium TLIF Cage. Patients undergoing transforaminal lumbar interbody fusions due to lumbar spinal pathology (i.e. central foraminal stenosis, degenerative disc disease, and/or lumbar spondylolisthesis) and have failed conservative care will be recruited for this study. Patients will be serially evaluated at 6 month intervals for a total of 24 months post index procedure to assess patient reported outcomes, clinical outcomes, and radiographic parameter, specifically spine fusion rates.
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature adults ages 35 - 80 years of age, inclusive
- •Diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral/bilateral foraminal stenosis
- •Subject undergoing one or two level transforaminal lumbar interbody fusion
- •Able to read and understand all documents used in this study , including the informed consent and patient-reported outcome questionnaires
排除标准
- •Patients over 80 years of age
- •Patients under 35 years of age
- •Current smokers
- •Subject has spondylolisthesis > 2
- •Subjects with multilevel >2 levels of symptomatic disease
- •Subjects with significant spinal deformity
- •Subject is pregnant, plans to become pregnant or is breast feeding
结局指标
主要结局
Radiographic Fusion
时间窗: 24 months
Fusion success measured by radiological assessment. Evidence of fusion demonstrated by bone formation through the cage on anteroposterior (AP) and Lateral radiographs, Flexion and Extension radiographs at 24 months
次要结局
- Back and Leg Visual Analog Scale (VAS)(12 months)
- Adverse Events(up to 24 months)
- Intervention Rates(up to 24 months)
- Oswestry Disability Index (ODI)(18 months)
- Back and Leg Visual Analog Scale(18 months)
研究者
Farhan Karim
Spine Surgeon
Hartford Hospital