Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels: A Clinical And Radiographic Analysis Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of successful cervical fusion measured radiographically
研究概览
简要总结
This is a prospective, single arm clinical study to evaluate fusion status and patient reported outcomes utilizing the Stryker Tritanium® C Anterior Cervical interbody device at one or two contiguous levels. Subjects that are recommended for surgical treatment of either a 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) between the levels of Cervical Spine 2 to Thoracic 1 (C2-T1) and diagnosed with degenerative disc disease will be screened for the study.
详细描述
Degenerative disc disease of the cervical (neck) spine occurs when the discs between the vertebral bony bodies start to deteriorate or break down due to wear and tear over time. It is diagnosed as such once it is symptomatic and causes neck pain and radiculopathy (arm pain, weakness, and/or numbness). In order to correct the damaged disc and resolve radicular symptoms, anterior cervical discectomy and fusion surgery is commonly performed.
This is a prospective, single arm clinical study to evaluate fusion status and patient reported outcomes utilizing the Stryker Tritanium® C Anterior Cervical interbody device at one or two contiguous levels. Subjects that are recommended for surgical treatment of either a 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) between the levels of C2-T1 and diagnosed with degenerative disc disease will be screened for the study. Subjects will be followed up postoperatively per standard of care at 6-weeks, 3-monts, 6-months, 12-months and at 24-months at the private practice or hospital clinic. The primary end-point is Successful cervical spinal fusion as measured by dynamic (flexion and extension) x-rays and CT scan (using metal subtraction) at 12 months and as evidenced by the following three criteria: bony bridging, no presence of radiolucency, and no development of pseudoarthrosis at the treated cervical level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients undergoing a one or two (contiguous) level primary ACDF between C2-T1
- •Able to provide consent
- •≥ 18 years of age and skeletally mature
- •Diagnosis of symptomatic degenerative disc disease, including; myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, spondylosis, osteophyte complexes, and foraminal stenosis
- •Neck pain and/or radicular symptoms with a baseline Visual Analog Scale score of ≥ 4 (0-10cm scale) for neck or arm pain
- •Baseline Neck Disability score ≥ 20
- •Had at least 6-weeks of conservative non-operative treatment and/or presents with increasing signs and symptoms of cervical myelopathy or radiculopathy that may require immediate intervention -
排除标准
- •1. Any prior history of cervical fusion
- •Requires cervical fusion of more than two levels or not contiguous levels
- •Acute cervical spine trauma requiring immediate intervention
- •Active systemic bacterial or fungal infection or infection at the operative site
- •History of vertebral fracture or osteoporotic fracture
- •Current treatment with chemotherapy, radiation, immunosuppression or chronic steroid therapy
- •History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal surgery
- •Psychological or physical condition in the opinion of the investigator that would interfere with completing study participation including completion of patient reported outcomes
- •History of neurological condition in the opinion of the investigator that may affect cervical spine function and pain assessments
- •Subjects with a history of cancer must be disease free for at least 3 years; with the exception of squamous cell skin carcinoma
- •Pregnant, or plans on becoming pregnant
- •History of allergy to titanium
结局指标
主要结局
Incidence of successful cervical fusion measured radiographically
时间窗: 12 months postoperative
Count of participants with successful cervical fusion as measured by CT scan of the cervical spine and flexion and extension view x-rays at 12-months postoperative as evidenced by the following three criteria: bony bridging, no presence of radiolucency, and no development of pseudoarthrosis at the treated cervical level(s).
次要结局
- Neck Disability Index for Pain and Function(24 months postoperative)
- Count of participants with revision surgery by month 12(24 months postoperative)
- Visual Analog Scale for Pain(24 months postoperative)
- Short Form Health Survey-36 for Quality of Life(24 months postoperative)
- Eating Assessment Tool - 10 for Dysphagia(24 months postoperative)
- Neurological Deficit as defined by Cervical Spine Examination(24 months postoperative)
- Count of participants with development of pseudoarthrosis by month 12(24 months postoperative)
研究者
Jad Khalil MD
Principal Investigator
Corewell Health East