Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Fusion rate
研究概览
简要总结
The purpose of this trial is to assess fusion rates in 3 and 4 level ACDFs in patients implanted with DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM. This will be a non-inferiority study, looking to show that Synthes Conduit 3D printed titanium cages fuse as well as cages.
详细描述
This is a prospective, single arm study of clinical and radiological outcomes from anterior cervical discectomy and fusions for cervical spondylosis. 58 Patients undergoing 3 to 4 level ACDF procedures from C2-T1 will be enrolled. Patients will be implanted with DePuy Conduit Titanium ACDF cage (DePuy Synthes, Raynham, MA). A retrospective comparision group will be used. The retrospective group will include 58 consecutive patients undergoing 3-4 level ACDFs with milled allograft.
This single-centered study will enroll up to 58 subjects, with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for three or four level anterior cervical fusion surgeries. The inclusion/exclusion criteria are listed below.
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
- •≥ 18 years old
- •Symptomatic multi-level degenerative cervical spondylosis necessitating anterior cervical arthrodesis in the subaxial cervical spine (between C2-T1).
- •Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)
- •Cervical x-rays at 24 months (±60 days; retrospective comparison group only)
排除标准
- •Traumatic spinal fractures or spinal cord injury
- •Previous cervical fusion surgery
- •Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator
- •Severe co-morbidities (e.g., heart, respiratory, or renal disease)
- •Recent (<3 yrs) or co-incident spinal tumor or infection
- •Concurrent involvement in another investigational drug or device study that could confound study data (prospective exclusion only)
- •History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
- •Subjects who are pregnant or plan to become pregnant in the next 24 months
- •Other contraindications for DePuy Conduit 3D printed titanium cage implant (prospective exclusion only)
结局指标
主要结局
Fusion rate
时间窗: 24 months
based on postoperative X-ray: presence of bone trabeculae across graft-host interface, absence of radiolucent gap between graft and adjacent vertebral body, restriction of motion to 2mm or less between adjacent vertebral spinous processes on flexion-extension lateral radiographs
次要结局
- Cervical sagittal alignment(24 months)
- Adverse events(24 months)
- Neurological assessment: Hoffman's and Spurlings(24 months)
- SF36 RAND(24 months)
- Reoperation(24 months)
- NRS(24 months)
- NDI(24 months)
- Neurological assessment: Upper Extremity Strength(24 months)
- number of days in the hospital(up to 24 months)
- Neurological assessment: Sensory function (C2-C7 dermatome)(24 months)
- Neurological assessment: Sensation is scored as absent (0), abnormal (1), or normal (2)(24 months)
研究者
Andrew Grossbach
Assistant Clinical Professor Residency Program Director Deformity and Robotic Spinal Fellowship Director
Ohio State University