NCT05777967进行中（未招募）3 期
A Phase 3 Single-arm Multicenter Study of FF-31501 in Meniscus Tear Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Lysholm score
研究概览
简要总结
A single-arm, multi-center study to verify that knee joint function at 52 weeks after injection of FF-31501 is better than at screening in patients with meniscus tear who are eligible for meniscectomy .
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
- •Patients with suspected meniscal flap tear
- •Patients with knee pain
- •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
- •Patients with poor knee alignment
- •Patients who underwent meniscus surgery or platelet rich plasma therapy
- •Patients with or history of knee ligament injury
- •Diabetic patients with poor glycemic control
- •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
- •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
Lysholm score
时间窗: Screening up to 52 weeks
It consists of items that measure: pain, instability, locking, swelling, limp, stair climbing, squatting, and need for support. Lowest and highest scores are 0 and 100 (better), respectively.
次要结局
- Knee injury and osteoarthritis outcome score (KOOS)(Screening up to the Day before injection,4,12,24 and 52 weeks)
- Numerical Rating Scale (NRS)(Screening up to the Day before injection,4,12,24 and 52 weeks)
- Arthroscopic assessment of the meniscus(Meniscus repair up to 52 weeks)
- Kellgren Lawrence(Screening up to 24 and 52 weeks)
研究者
研究点 (4)
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