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临床试验/NCT04041583
NCT04041583招募中不适用

Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers

Ohio State University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
Cervical Sagittal Alignment Parameters

研究概览

简要总结

This is a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS. Data will be collected from medical records for up to 730 days after surgery. Data to be collected will be demographic, preoperative clinical information, surgical details, and radiographic information. Patients will also undergo a non-standard of care CT scan 2 years after surgery.

详细描述

Background and Rationale

Posterior cervical fusion surgeries are performed for degenerative cervical conditions, cervical deformity, cervical tumors, and cervical trauma. They are preferred over an anterior approach when the pathology is located posterior to the spinal cord or when multiple levels must be addressed. Degenerative cervical spondylosis contributes to loss of disc height, facet arthropathy and hypertrophy, and retrolisthesis of the vertebral bodies, all of which can lead to foraminal stenosis, or narrowing around the exiting nerve roots. This is often accompanied by loss of cervical lordosis. During a posterior fusion operation, the restoration of cervical lordosis can worsen this foraminal stenosis and lead to iatrogenic radiculopathy with and estimated incidence between 2.4-50%. Cadaveric studies have shown the insertion of interfacet spacers in the cervical spine increase foraminal height, and serve to indirectly decompress the exiting nerve roots. Another common complication of cervical spine surgery is C5 palsy, which has been reported in 4.6% of patient undergoing posterior cervical spine decompressive procedures, including decompression and fusion. Patients suffering from iatrogenic C5 palsy have significantly increased recovery times, and often require additional services such as imaging studies (CT, MRI) and increased need for physical and occupational therapy, thus increasing costs. Given the ability to decompress the neuroforamen with interfacet spacers, they could potentially be an effective technique for reducing the incidence of C5 palsy.

The use of cervical interfacet spacers (CIS; CORNERSTONE Facet MicroGrafts, Medtronic, Minneapolis, MN) is a relatively novel technique shown to be useful for posterior fusion to address symptomatic pseudoarthrosis (fusion failure) after anterior cervical arthrodesis. CIS have a relatively large osteoconductive surface area and are placed under tension in the interfacet space, which together favorably influence bony fusion. Current techniques for posterior cervical fusion rely on graft placement using bone extenders placed in the posterolateral space, which is not under a compressive load. Wolfe's law dictates that certain amounts of loading of bone grafts is required to achieve bony fusion. Therefore, the use of CIS could potentially increase fusion rates after posterior cervical arthrodesis procedures and reduce or eliminate the need for use of bone graft extenders. Reassuringly, radiologic studies have shown that despite the increase in foraminal height, the use of CIS does not lead to loss of cervical lordosis.

Study Objective

To date, there have been no prospective studies examining the use of cervical interfacet spacers. The investigators propose to undertake a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • ≥ 18 years old
  • Symptomatic multi-level degenerative spondylosis necessitating posterior cervical arthrodesis in the subaxial cervicothoracic spine (between C2-upper thoracic).
  • Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)

排除标准

  • Traumatic injury
  • 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
  • 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

结局指标

主要结局

Cervical Sagittal Alignment Parameters

时间窗: 2-Years

Cervical Sagittal Alignment Parameters measured on post-operative radiographs

Cervical Fusion

时间窗: 2-Years

Cervical Fusion Measured on Post-Operative Radiographs and CT scans

次要结局

  • NRS(2-Years)
  • NDI(2-Years)
  • SF-36 RAND(2-Years)
  • Neurological Adverse Events(2-Years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Grossbach

Principal Investigator, Assistant Clinical Professor

Ohio State University

研究点 (1)

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