NCT00945243终止不适用
Prospective, Multi-Center Clinical Outcomes Study Evaluating the Zero-P PEEK for Anterior Cervical Interbody Fusion in the Treatment of Cervical Degenerative Disc Disease
Synthes USA HQ, Inc.28 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2009年7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
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 28
- 主要终点
- Assessment of Neck Disability Index Scores
研究概览
简要总结
This is a multi-center, prospective, outcomes study. In this study, the Zero-P PEEK implant will be used in patients undergoing ACDF for treatment of SCDD at a single level between C3 and C7. The cohort will be followed over time to twenty-four (24) months after surgery. Up to fifteen (15) sites will participate in this study. This is not a controlled study.
详细描述
This was a post-market study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic cervical disc disease (SCDD) in only one vertebral level between C3-C7 requiring:
- •Neck or arm (radicular) pain and/or
- •Functional/neurological deficit confirmed by imaging (CT, MRI, X-Ray) of at least one of the following:
- •i. herniated nucleus pulposus
- •ii. spondylosis (defined by presence of osteophytes)
- •iii. loss of disc height
- •NDI score greater than or equal to 15/50 (30%) (considered moderate disability);
- •Skeletally mature adult between the ages of 18-70 years at the time of surgery;
- •Has completed at least six (6) weeks of conservative therapy;
- •Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
- •Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
排除标准
- •More than one vertebral level to be fused;
- •Posterior instrumentation necessary at same level;
- •Has had previous surgery at the index level;
- •Has a fused level adjacent to the index level;
- •Active systemic or local infection;
- •Known or documented history of communicable disease, including AIDS or HIV;
- •Active hepatitis (receiving medical treatment within two years);
- •Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing;
- •Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months;
- •Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
- •Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score ≤ -1.
- •Previous known allergy to the materials contained in the device, such as polyetheretherketone (PEEK) or titanium alloy (TAN);
- •Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight;
- •Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
- •Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
- •Pregnant or planning to become pregnant during study period;
- •Involved in study of another investigational product that may affect outcome;
- •History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
- •Patients who are incarcerated.
研究组 & 干预措施
Treatment
Other
Treatment of cervical DDD with the Zero-P device
干预措施: Zero-P (Device)
结局指标
主要结局
Assessment of Neck Disability Index Scores
时间窗: 24 months
Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.
次要结局
- Implant Related Complications(24 months)
- Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)(24 months)
研究者
研究点 (28)
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