ACTRN12611000646943招募中4 期
A multi-center, prospective, randomised controlled trial comparing the efficacy and safety of PRODISC-C (Registered Trade Mark) implant to anterior cervical discectomy and fusion (ACDF) surgery, in the treatment of symptomatic cervical disc disease (SCDD)
Synthes Asia Pacific0 个研究点目标入组 300 人开始时间: 2011年6月23日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.Subjects with symptomatic cervical disc disease (SCDD) in only 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 (Computed Tomography scans, Magnetic Resonance Imagings or X-rays)
- •-Herniated nucleus pulposus
- •-Spondylosis (defined by the presence of osteophytes)
- •-Loss of disc height
- •2.Unresponsive to non-operative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root compression in the face of conservative treatment.
- •3.Neck Disability Index (NDI) score greater than or equal to 15/50 (30%) (Considered moderate disability).
排除标准
- •1.More than one vertebral level requiring treatment (showing marked changes at a second level)
- •Marked cervical instability on resting lateral or flexion/extension radiographs:
- •a.translation greater than 3 mm and/or
- •b.greater than 11 degrees of rotational difference to that of either adjacent level .
- •2.Radiographic confirmation of severe facet joint disease or degeneration.
- •3.Known allergy to cobalt, chromium, molybdenum, titanium or polyethylene.
- •Clinically compromised 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.
- •4.Severe spondylosis at the level to be treated as characterized by any of the following:
- •- Bridging osteophytes;
- •- A loss of disc height greater than 70%
- •- Absence of motion (<2 degrees).
- •5.Neck or arm pain of unknown etiology.
- •6.Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require
- •a Dual Energy X-ray Absorptiometry (DEXA) bone mineral density measurement. If DEXA is required, exclusion will be defined as a DEXA bone density measured T-score < -2.5 (The World Health Organization definition of osteoporosis. )
- •7.Paget’s disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
- •8.Severe diabetes mellitus requiring insulin management
- •9.Pregnant
- •10.Active infection - systemic or local.
- •11.Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
- •12.Rheumatoid arthritis or other autoimmune disease.
- •13.Systemic disease including AIDS, HIV, hepatitis.
- •14.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.
- •15.Workers compensation or action compensation patients (at the surgeons discretion).
- •16.Subjects involved in other trials within the last month, prior to screening.
- •17.Subjects refused to agree to either ProDisc-C or Anterior Cervical Discectomy and Fusion (ACDF) treatment.
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