A Multi-Center Study to Evaluate MiLIF(R) Versus Open Posterior Unilateral Lumbar Interbody Fusion (TLIF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 9
- 主要终点
- Clinical Outcomes
研究概览
简要总结
This study is being undertaken to compare the clinical outcomes of patients that have unilateral posterolateral lumbar interbody fusion using a traditional open approach versus the MiLIF procedure based on the MiCOR Precision Bone Allograft, specialized Atavi instrumentation, and minimally invasive visualization capabilities.
详细描述
This is a prospective, multi-center, non-randomized cohort design clinical study to evaluate the clinical outcomes of patients that have a minimally invasive lumbar interbody fusion (MiLIF) through the Atavi system compared to traditional unilateral open lumbar interbody fusion through a midline incision. the study will involve up to approximately 12 investigational sites and enroll up to 126 patients.
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
- •Patient is between 18 and 75 years of age
- •Patient is scheduled for an elective spinal lumbar interbody single level fusion
- •Patient is a candidate for posterior unilateral lumbar fusion through a midline incision
- •Indication for surgery and dominant symptom of chronic low back and/or leg pain
- •Diagnosis of one or more of the following:
- •Primary symptomatic degenerative disc disease confirmed with appropriate imaging studies and/or positive lumbar discography
- •Spondylolisthesis Grade I/II
- •The affected motion segment reside in L2-S1 and are adjacent segments
- •Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure.
排除标准
- •Patient has a known fracture in the lumbar spine
- •Patient has systemic infection or evidence of any surgical site infection (superficial or organ space)
- •Patient has compromised immune system or autoimmune disease (WBC<4000 or >20,000)
- •Patient has uncontrolled diabetes
- •Patient has a known malignancy
- •Prior lumbar fusion attempt; prior laminectomy and/or discectomy are allowed
- •Known medical or anatomical condition that would preclude a posterior lumbar fusion using metallic instrumentation (e.g., severe osteopenia)
- •Patient with a planned placement of an electric bone stimulator
- •Patient with a planned placement of indwelling epidural catheter for a long term pain management
- •Patient is pregnant or wishes to become pregnant during the length of the study participation
- •Patient is currently in litigation
- •Patient is not likely to comply with the follow-up evaluation schedule
- •Patient is participating in a clinical trial of another investigational drug or device.
结局指标
主要结局
Clinical Outcomes
时间窗: MiLIF and Open groups at 3 months post-procedure as defined by the mean Oswestry score
次要结局
- Clinical Outcomes(The percent of patients that have a successful fusion at one year post-procedure as measured by radiographs)