Clinical study on treatment for meniscal defect using collagen-based construct.

JRCT ID: jRCTs052180065

Registered date:18/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Meniscal Injury
• Date of first enrollment: 23/02/2016
• Target sample size: 35
• Study type: Interventional

Intervention(s)

Meniscus repair
Collagen-based construct implantation at meniscal defect

Outcome(s)

Primary Outcome

Evaluation of the safety:
Adverse event data, including type, frequency, severity and duration.

Evaluation of the efficacy:
Evaluation of the subjective symptoms before and after the implantation of collagen-based construct at meniscal defect by Knee Injury and Osteoarthritis Outcome Score (KOOS)

Secondary Outcome

Secondary Outcomes of the safety:
Laboratory evaluations
1)Hematology
2)clinical chemistry
3)urinalysis

Secondary Outcomes of the efficacy:
1)Subjective score by KOOS and VAS
2)Repair site morphology by MRI
3)Activity score by Lysholm and Tegner
4)Arthroscopic evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

1) Patients who are diagnosed as meniscus injury by MRI
2) Patients with drug-uncontrollable knee pain
3) Patients who are between 16 and 60 years old
4) Patients (in case a patient is between 16 and 19 years old, both the proxy and the patient) whom the researchers obtain the written consent
5) Patients who has meniscus defect more than 10 mm2 after trimming

Exclude criteria

1) Meniscal injury patients who need operation and treatment
2) Patients with knee osteoarthritis of Kellgren-Lawrence grade III or IV
3) Patients with allergic or atopic tendency
4) Patients with infections (positive for HIV, HBV, HCV, or HTLV)
5) Patients with active cancer
6) Pregnant or possibly pregnant patients, patients giving the breast to a child or expecting a child during the study periods
7) Psychopathic patients who are considered noncompliant, or unable to understand the significance of this study
8) Patients whom the researchers judge to be inappropriate to be enrolled in this study

Related Information

• Primary Sponsor: Nakata Ken
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000014587