A Pivotal, Multi-Center, Randomized, Controlled Trial Evaluating The Safety and Effectiveness of The NeoDisc™ Versus Instrumented Anterior Cervical Discectomy and Fusion (ACDF) in Subjects With Single-Level Cervical Disc Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 488
- 试验地点
- 44
- 主要终点
- Improve in NDI by ≥ 15 pnts at 24 mo compared to Baseline; No device failures requiring revision, re-op or removal; No major complications,i.e.,vascular or neurological injury; Maintenance or improvement of neurologic status
研究概览
简要总结
The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2) revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement in neurologic status.
详细描述
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy. Implantation of the device will result in artificial replacement of a pathologically damaged or surgically removed cervical disc. Use of the device also obviates the need to harvest bone graft from the patient's iliac crest, a common and painful part of current surgical techniques.
The NeoDisc is indicated for cervical spinal arthroplasty in skeletally mature subjects with symptomatic cervical disc disease at one level from C3 to C7. Symptomatic cervical disc disease is defined as image-confirmed herniated disc, spondylosis, and/or loss of disc height, with functional neurological deficit (i.e., exhibits at least one sign associated with cervical level to be treated, including abnormal reflex, decreased motor strength, abnormal dermatome sensitivity, or pain in a dermatomal distribution).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-60 years of age (inclusive and skeletally mature)
- •Diagnosis of symptomatic cervical disc disease, defined as image- confirmed pathology: herniated disc, spondylosis, and/or loss of disc height. Spondylosis is defined as MRI or CT-confirmed disc dessication, loss of disc height, bridging osteophytes, and/or uncovertebral arthrosis. Loss of disc height is specified as a measurement of at least 25% less than an adjacent nonsymptomatic level, but with a minimum of 1mm height remaining.
- •Functional neurological deficit (i.e., exhibits at least one sign associated with cervical level to be treated, including abnormal reflex, decreased motor strength, abnormal dermatome sensitivity, or pain in a dermatomal distribution)
- •Symptomatic level is C3-4, C4-5, C5-6 or C6-7 (one level)
- •Preop NDI ≥30 points
- •Unresponsive to conservative treatment for ≥6 wks, or exhibits progressive symptoms or signs of nerve root or spinal cord compression in the face of conservative treatment
- •Not pregnant, nor interested in becoming pregnant within the follow-up period of the study
- •Willing and able to comply with the requirements defined in the protocol for the duration of the study
- •Signed and dated Informed Consent
排除标准
- •Prior cervical fusion surgery at the operative level
- •Prior cervical laminectomy at the operative level (prior cervical laminotomy need not be excluded)
- •Prior cervical complete facetectomy at the operative level
- •Requiring surgical treatment that would leave the patient with a postoperative deficiency of the posterior elements
- •Radiographic signs of significant instability at operative level (greater than 3mm translation, > 11 degrees rotation different from adjacent level)
- •Bridging osteophytes or motion < 2 degrees
- •Radiographic confirmation of significant facet joint disease or degeneration
- •Chronic neck or arm pain of unknown etiology
- •Clinically significant symptomatic myelopathy (e.g., those with signal changes in the spinal cord on preoperative T2-weighted MRI)
- •Cervical fracture, anatomic anomaly, or deformity (e.g. ankylosing spondylitis, scoliosis) at the levels to which the prosthesis will be attached
- •Severe spondylolisthesis (>grade 1)
- •Endocrine disorders or connective tissue diseases
- •Rheumatoid arthritis or other autoimmune disease
- •Progressive neuromuscular disease, e.g., muscular dystrophy, multiple sclerosis
- •Chronic steroid users
- •Taking any medications or drugs that are known to potentially interfere with the bone metabolism or soft tissue healing, which may include (but is not limited to) the following: inhaled glucocorticoids for asthma, corticosteroids, thyroid hormones, blood thinners (heparin, warfarin), gonadotropin-releasing hormone agonists for prostate cancer treatment, contraceptive medroxyprogesterone, lithium for bi-polar disorder treatment, anticonvulsants, aluminum-containing antacids, tetracycline
- •Osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated (DEXA T-score less than or equal to -2.5; DEXA necessary only if patient exhibits risk factors for low bone mass as quantified in DEXA screening questionnaire).
- •Diabetes mellitus requiring insulin management
- •Presence of metastases or active spinal tumor malignancy
- •Body Mass Index (BMI) > 40
- •Active local or systemic infection, including AIDS, hepatitis
- •Having been enrolled in another investigational device study within the last 90 days
- •Having had another cervical device implanted that would interfere with the surgical approach, study or control device, or follow-up evaluations.
- •Demonstrates signs of nonorganic behavior, such as Waddell's signs
- •History of substance abuse
- •Involved in spinal litigation
- •Mentally incompetent
- •Incarcerated
结局指标
主要结局
Improve in NDI by ≥ 15 pnts at 24 mo compared to Baseline; No device failures requiring revision, re-op or removal; No major complications,i.e.,vascular or neurological injury; Maintenance or improvement of neurologic status
时间窗: August 2010
次要结局
- ROM; Fusion/migration of device; SF-36 imp of ≥15% at 24 months comp to Baseline; VAS imp of > 20 mm at 24 months comp to Baseline; Disc ht from lateral x-ray showing maintenance or imp from Baseline at 24(August 2010)