NCT01982266终止不适用
A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a prospective, multicenter, single arm feasibility study of the safety and performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require cartilage replacement.
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
- •Primary hip surgery for Noninflammatory Degenerative Joint Disease (NIDJD) such as osteo/degenerative arthritis, and is indicated for cartilage replacement
- •Skeletally mature or at least 18 years of age and has normal anatomy
- •Patient signs the Informed Consent form
- •Failed medical management
- •There will be size limitations on patients also - available size range is 46mm-54mm.
排除标准
- •Allergic to polyether urethane, sodium polyacrylate, bone cement or any of its components
- •Previous fusion, acute femoral neck fracture and/or above knee amputation
- •Revision of any previous hip procedure
- •Slipped capital femoral epiphysis (SCFE)
- •Rheumatoid arthritis
研究组 & 干预措施
GRADION™ Hip Total Cartilage Replacement (TCR)™
Experimental
干预措施: GRADION™ Hip Total Cartilage Replacement (TCR)™ (Device)
结局指标
主要结局
Adverse events
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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