NCT01609374Unknown不适用
Prospective, Non-Randomized, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics™ M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Symptomatic Cervical Radiculopathy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 258
- 主要终点
- Safety Evaluation through 24 months
研究概览
简要总结
This is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression. Some participating sites will enroll just M6-C patients, while others will enroll just ACDF patients.
Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at one vertebral level from C3 to C7.
A total of 243 subjects will be included at up to 20 sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
since the study is concurrently controlled, masking is not possible
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
- •Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at one level from C3 to C7 demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (e.g. neck and/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies (e.g. MRI, CT, x-rays, etc.)
- •Inadequate response to conservative medical care over a period of at least 6 weeks
- •Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
- •Neck or arm pain VAS ≥ 4 on a scale of 0 to 10
- •Willing and able to comply with the requirements of the protocol including follow-up requirements
- •Willing and able to sign a study specific informed consent
- •Skeletally mature and ≥ 18 years old and ≤ 75 years old
排除标准
- •More than one cervical level requiring surgery
- •Previous anterior cervical spine surgery
- •Axial neck pain as the solitary symptom
- •Previous posterior cervical spine surgery (e.g., posterior element decompression) that destabilizes the cervical spine
- •Advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative or adjacent levels
- •Symptomatic facet arthrosis
- •Less than 4º of motion in flexion/extension at the index level
- •Instability as evidenced by subluxation > 3 mm at the index or adjacent levels as indicated on flexion/extension x-rays
- •Advanced degenerative changes (e.g., spondylosis) at the index vertebral level as evidenced by bridging osteophytes, central disc height < 4mm and/or < 50% of the adjacent normal intervertebral disc, or kyphotic deformity > 11º on neutral x-rays
- •Severe cervical myelopathy (i.e., Nurick's Classification > 2)
- •Active systemic infection or infection at the operative site
- •Co-morbid medical conditions of the spine or upper extremities that may affect the cervical spine neurological and/or pain assessment
- •Metabolic bone disease such as osteoporosis that contradicts spinal surgery (for females over 50 and males over 55 years old, or if the score on the Osteoporosis Self-Assessment Test is < 2, a dual energy x-ray absorptiometry [DEXA scan] of the spine is required; if the bone mineral density T-score in the spine is ≤ -2.5 the patient must be excluded)
- •History of an osteoporotic fracture of the spine, hip or wrist
- •History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
- •Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
- •Known allergy to titanium, stainless steels, polyurethane, polyethylene, or ethylene oxide residuals
- •Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
- •Insulin-dependent type 1 or type 2 diabetes
- •Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
- •Pregnant, or intend to become pregnant, during the course of the study
- •Severe obesity (Body Mass Index > 40)
- •Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life.
- •Involved in current or pending spinal litigation where permanent disability benefits are being sought
- •Incarcerated at the time of study enrollment
- •Current participation in other investigational study that may impact study outcomes
研究组 & 干预措施
M6-C Artificial Cervical Disc
Experimental
干预措施: M6-C Artificial Cervical Disc (Device)
Anterior Cervical Discectomy and Fusion
Active Comparator
干预措施: Anterior plate system with corticocancellous allograft bone (Device)
结局指标
主要结局
Safety Evaluation through 24 months
时间窗: 24 months
Evaluate the safety by assessing adverse events and neurological function following implantation with the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)
Effectiveness Evaluation through 24 months
时间窗: 24 months
Evaluate the effectiveness using Neck Disability Index (NDI)
次要结局
- Effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)(6 weeks, 3 months, 6 months, 12 months, 24 months)
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