jRCT2073220083进行中（未招募）不适用
A Phase 3 single-arm multicenter study of FF-31501 in meniscus tear patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •1.Patients with suspected meniscus flap tear
- •2.Patients with knee pain
- •3.Patients with one or more of the following symptoms
- •Feeling stuck in the knee
- •Instability of the knee
- •Knee range of motion impairment
- •Knee joint edema
排除标准
- •1.Patients with poor knee alignment
- •2.Patients who underwent meniscus surgery or platelet rich plasma therapy
- •3.Patients with or history of knee ligament injury
- •4.Diabetic patients with poor glycemic control
- •5.Patients with the following complications and poor general condition
- •Severe cardiovascular disease
- •Severe liver disease
- •Severe renal dysfunction
- •Severe anemia
- •uncontrolled mental illness
- •Other diseases for which sudden change or worsening of symptoms can be expected during study participation
- •6.Patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period
结局指标
主要结局
-
Changes in Lysholm score after injection
次要结局
- Arthroscopic assesment of the meniscus(before and 52 weeks after injection)
- Changes in KOOS(after injection)
- Changes in NRS(after injection)
研究者
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