A Phase 3study of FF-31501 in meniscus tear patients

Phase 3

Active, not recruiting

Conditions: Meniscus injuries indicated for meniscectomy

Registration Number: JPRN-jRCT2073220083

Lead Sponsor: Sakurai Tsutomu

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 18

Inclusion Criteria

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
4.Other

Exclusion Criteria

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
7.Other

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Lysholm score after injection

Secondary Outcome Measures

Name	Time	Method
Arthroscopic assesment of the meniscus before and 52 weeks after injection of FF-31501<br>Changes in KOOS after injection<br>Changes in NRS after injection