NCT02039232已完成不适用
CarboFix Pedicle Screw System
CarboFix Orthopedics Ltd.3 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2014年1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
- 46
- 试验地点
- 3
- 主要终点
- Fusion success
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years old or older.
- •Confirmation that the physical examination of radiopathy, myelopathy or combination is in correlation with the affected level.
- •Lumbar CT, MRI, or myelography confirms the level of involvement is consistent with the subject's examination.
- •Informed consent given by the subject.
排除标准
- •Subject is not eligible for fixation with market-available fixation means.
- •Familial history NF
- •Acute traumatic spinal injury with or without neurological signs.
- •Metabolic bone disease.
- •History of Paget's disease or other osteodystrophies whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism hyperparathyroidism, Ehrlers-Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.
- •History of mental disorder or current psychiatric treatment.
- •Pregnancy and/or female subjects intending to become pregnant within the expected time frame of the study and/or female subjects of child bearing age who do not use conventional contraceptive methods.
- •Immune deficiency disease.
- •Infection in the location of the operative site, discitis, osteomyelitis, fever and/or leukocytosis (as diagnosed based on the results of CBC and ESR tests).
- •Treatment with drugs that may interfere with bone metabolism such as:
- •Cumulative dose of 150 mg. of Prednisone or equivalent within the last 6 months.
- •Calcitonin within the past 6 months.
- •Bisphosphonates for 30 days or more within the last 12 months.
- •Bone therapeutic doses of fluoride for 30 days or more within the last 12 months.
- •Bone therapeutic doses of vitamin D or Vitamin D metabolites for 30 days or more within the last 6 months.
- •Treatment by chemotherapy within the last 12 months.
- •Lack of willingness to make a commitment to return for required follow up visits.
- •Drug and/or alcohol abuse.
- •Morbid obesity.
- •Metal allergies.
- •Recent use of other investigational drugs or devices (within the past 30 days).
结局指标
主要结局
Fusion success
时间窗: 6 months post-operation
次要结局
未报告次要终点
研究者
研究点 (3)
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