NCT00291018已完成不适用
A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc-C to Anterior Cervical Discectomy and Fusion (ACDF) Surgery in the Treatment of Symptomatic Cervical Disc Disease (SCDD)
Synthes USA HQ, Inc.0 个研究点目标入组 368 人开始时间: 2003年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 368
- 主要终点
- Overall Success
研究概览
简要总结
The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD).
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; and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI or X-rays): Herniated nucleus pulposus; Spondylosis (defined by the presence of osteophytes); and/or Loss of disc height.
- •Age between 18 and 60 years.
- •Unresponsive to non-operative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment.
- •NDI score greater than or equal to 15/50 (30%).
- •Psychosocially, mentally and physically able to fully comply with the protocol including adhering to follow-up schedule and requirements and filling out forms.
- •Signed informed consent.
排除标准
- •More than one vertebral level requiring treatment.
- •Marked cervical instability on resting lateral or flexion/extension radiographs: translation greater than 3mm and/or greater than 11 degrees of rotational difference to that of either adjacent level.
- •Has a fused level adjacent to the level to be treated.
- •Radiographic confirmation of severe facet joint disease or degeneration.
- •Known allergy to cobalt, chromium, molybdenum, titanium or polyethylene.
- •Clinically comprised vertebral bodies at the affected level(s) due to current or past trauma, e.g. by the radiographic appearance of fracture callus, malunion or nonunion.
- •Prior surgery at the level to be treated.
- •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: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA (dual energy x-ray absoptiometry) bone mineral density measurement. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score less than or equal to -2.5 (the World Health Organization definition of osteoporosis).
- •Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
- •Severe diabetes mellitus requiring daily insulin management.
- •Pregnant or interested in becoming pregnant in the next three years.
- •Active infection - systemic or local.
- •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 have been no clinical signs or symptoms of the malignancy for at least 5 years.
研究组 & 干预措施
ProDisc-C
Experimental
ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7
干预措施: Total Disc Replacement (Device)
Control
Active Comparator
ACDF
干预措施: ACDF (Device)
结局指标
主要结局
Overall Success
时间窗: 84 Months
Sponsor Definition of Overall Success: (1) Subject's NDI score improved by at least 20% over preoperative baseline value (2) Subject's neurologic parameters, i.e. motor, sensory, and reflexes were maintained or improved as compared to preoperative baseline value (3) No removals, revisions, re-operations, or additional fixation were required to modify any implant (4) No adverse events occurred which were related to the treatment, ProDisc-C or its implantation or ACDF surgery or its associated implants or graft material
次要结局
- SF-36 Mental Composite Score (MCS)(84 Months)
- VAS Satisfaction(84 Months)
- Neurologic Success(84 months)
- NDI(84 months)
- SF-36 Physical Composite Score (PCS)(84 Months)
- VAS Neck Pain Intensity(84 Months)
- VAS Neck Pain Frequency(84 Months)
- VAS Arm Pain Frequency(84 Months)
- VAS Arm Pain Intensity(84 Months)
- Surgery Again(84 Months)
研究者
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