ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- AlloSource
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Long-Term Outcomes of ProChondrix CR
研究概览
简要总结
The primary objective of this registry is to obtain long-term outcomes on ProChondrix CR in cartilage repair procedures of the knee, ankle, foot and hip.
详细描述
This multi-center, observational registry will be used to evaluate the effectiveness of ProChondrix CR in patients who undergo treatment for an articular cartilage defect in the knee, ankle, foot or hip.
This registry will be performed at up to 30 clinical sites across the United States.
Patient follow-up will occur following an articular cartilage repair procedure in which the patient receives ProChondrix CR. During this follow-up period, each patient will be evaluated at least four (4) times at: 3, 6, 12 and 24 months after surgical intervention and will continue annually for as long as patients are willing to fill out questionnaires and outcomes assessments up to 10 years post operatively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed by physician to have a cartilage defect in the knee, ankle, foot or hip that requires surgical intervention;
- •Will be having, or has had, a cartilage repair procedure using ProChondrix CR;
- •Has the ability to understand the requirements of the registry, to provide written informed consent and to comply with the registry protocol;
排除标准
- •Is a ward of the state, prisoner, or transient.
结局指标
主要结局
Long-Term Outcomes of ProChondrix CR
时间窗: 10 Years Post-Operative
Obtain long-term results on patients who have undergone an articular cartilage repair procedure using ProChondrix CR, as assessed by patient reported outcomes.
次要结局
未报告次要终点