NCT02252185已完成不适用
A Prospective, Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Safety and Efficacy of a Spine Fusion System in Vertebral Body Fusion Surgery
Johnson & Johnson Medical (Suzhou) Ltd.8 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 8
- 主要终点
- Change of Japanese Orthopaedic Association score
研究概览
简要总结
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
详细描述
This study is a prospective, multicenter, randomized, comparative, non-inferiority study comparing the change of Japanese Orthopaedic Association Score from baseline at postoperative 24 weeks for patients implanted with local made Spine Fusion System versus imported products.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20-70 years old, male or female;
- •Subject being diagnosed as having disc degeneration disease, spondylolisthesis, spinal fracture, deformity(degenerative deformity), spinal stenosis, or spinal tumor, has been treated with conservative treatment without relief or getting worse, who is suitable for surgery according to clinic practice.
- •Subject is a suitable candidate for implanting investigational products described in study protocols according to investigator's assessment;
- •Patient, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and willing to be available for each required study procedure over the study duration.
- •Subject has been given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to study Sponsor.
排除标准
- •Patient has a local or systemic infection.
- •Patient has had one or more previous non-fusion spinal surgery at the involved level(s).
- •Patient without spinal deformity and requires fusion at 3 or more levels.
- •Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
- •Has presence of active malignancy
- •Has a medical condition with less than 1 year of life expectancy.
- •Pregnancy or women in lactation period.
- •Is grossly obese, i.e. Body Mass Index≥
- •Has a diagnosis, which requires postoperative medication or treatment that interferes with fusion, such as steroids, chemotherapy, radiotherapy, growth factor (for more than 3 months), Nonsteroidal Antiinflammatory Drugs(for more than 3 months), and etc.
- •Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. uncontrolled Diabetes with medication, renal osteodystrophy, or osteogenesis imperfect)
- •Alcoholic (taking more than 40g/day, equals to 100ml 50°Chinese liquor), smoking more than 40 cigarettes/day, or Drug abuser;
- •Is currently participating in another investigational drug or device study.
结局指标
主要结局
Change of Japanese Orthopaedic Association score
时间窗: Preoperation and 24week post operation
Questionnaire
次要结局
- Visual Analogue Score of low back and leg pain(7day, 12week, and 24week post operation)
- Wound healing(7day, 12week, and 24week post operation)
- Improvement rate of Japanese Orthopaedic Association score(7day, 12week, and 24week post operation)
- Fixation stability(12week, and 24week post operation)
研究者
研究点 (8)
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