NCT00882661已完成不适用
A Prospective Randomized Clinical Investigation of the SECURE-C Cervical Artificial Disc: A Pivotal Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 主要终点
- Individual Patient Overall Success
研究概览
简要总结
The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7, compared to anterior cervical discectomy and fusion.
The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc
详细描述
Ages Eligible for Study: 18 to 60 years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7, defined as neck or arm (radicular) pain, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:
- •Herniated nucleus pulposus;
- •Radiculopathy or myelopathy;
- •Spondylosis (defined by the presence of osteophytes); or
- •Loss of disc height.
- •Age between 18 and 60 years
- •Failed at least 6 weeks of conservative treatment
- •Neck Disability Index (NDI) Questionnaire score of at least 30 (as percentage of 50 point total)
- •Able to understand and sign informed consent form
- •Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and filling out forms
- •Able to meet the proposed follow-up schedule at 6 weeks, 3 months, 6 months, 12 months and 24 months
- •Able to follow postoperative management program
排除标准
- •More than one vertebral level requiring treatment
- •Prior fusion surgery adjacent to the vertebral level being treated
- •Prior surgery at the level to be treated
- •Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
- •Radiographic confirmation of facet joint disease or degeneration, defined as apparent sclerosis and/or hypertrophy of the facets demonstrated on AP radiographs as a disruption of the normally smooth facet curve
- •Marked cervical instability on resting lateral or flexion/extension radiographs:
- •Translation greater than 3mm, and/or
- •More than 11° of rotational difference from that of either adjacent level.
- •Severe spondylosis at the level to be treated as characterized by any of the following:
- •Bridging osteophytes;
- •A loss of disc height greater than 50%; or
- •Absence of motion (<2°)
- •Neck or arm pain of unknown etiology
- •Osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease
- •Pregnant or interested in becoming pregnant in the next 2 years
- •Active systemic or local infection
- •Known allergy to titanium, polyethylene, cobalt, chromium or molybdenum
- •Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids)
- •Rheumatoid arthritis or other autoimmune disease
- •Systemic disease including AIDS, HIV, Hepatitis
- •Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years
- •Neuromuscular disorders such as muscular dystrophy, spinal muscular atrophy, amyotrophic lateral sclerosis, etc.
- •Acute mental illness or substance abuse
- •Use of bone growth stimulator within past 30 days
- •Participation in other investigational device or drug clinical trials within 30 days of surgery
- •Prisoners
结局指标
主要结局
Individual Patient Overall Success
时间窗: 24 months
Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion
次要结局
- SF-36 MCS(24 months)
- Neck Disability Index (NDI)(24 months)
- Neck Pain Visual Analog Scale (VAS)(24 months)
- Left Arm Pain Visual Analog Scale (VAS)(24 months)
- Satisfaction(24 months)
- Right Arm Pain Visual Analog Scale (VAS)(24 months)
- SF-36 PCS(24 months)
研究者
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