A Post Approval Study to Evaluate the Safety and Effectiveness of Cartiva Implant in the Treatment of First Metatarsophalangeal Joint Osteoarthritis as Compared to a Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 主要终点
- Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise
研究概览
简要总结
Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.
详细描述
As part of the Conditions of Approval of Cartiva SCI for the treatment of first MTP osteoarthritis, the Food and Drug Administration (FDA) requires additional long term data to evaluate the long term safety and effectiveness of Cartiva including the durability and survivorship of the implant. This Post-Approval Study (PAS) addendum is intended to supplement the initial 24 months follow up period and provide additional long term safety and effectiveness data on Cartiva
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 must have been treated with Cartiva under MOTION study protocol PTC-0031; and,
- •Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the IRB/Ethics Committee for long-term follow-up.
排除标准
- •Subjects who underwent a secondary surgical intervention to have the Cartiva implant removed during the 24-month time period of participation in the MOTION study.
研究组 & 干预措施
Cartiva
Cartiva Synthetic Cartilage Implant
干预措施: Cartiva (Device)
结局指标
主要结局
Long Term Safety of the Cartiva Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise
时间窗: 5 year
1. Durability of the implant over the longer term. This will be addressed using survival analysis starting at Month 24 to determine the rate of implant removals among devices that survived to Month 24. A complementary survival analysis starting at index surgery to end of study will also be performed. 2. There are no unanticipated safety concerns that arise after Month 24 up to 5 years. This will be addressed by a) determining the incidence of serious device-related adverse events per year and overall from Month 24 to Year 5; and b) summarizing device-related radiographic complications1 over time from Month 24 to Year 5. Note that this analysis will address both device and procedure related complications and serious device-related adverse events whether observed previously in the 24 month follow up portion of the study or encountered for this first time during the extended follow-up period.
次要结局
- Pain Scale (VAS)(5 year)
- Foot and Ankle Ability Measure (FAAM) Sports(5 year)
- Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL)(5 year)