Clinical Trial for Efficacy and Safety of ARtificial Protein (Silk-elastin, P47K-WAS-MR) in Patients with Meniscus Repair

JRCT ID: jRCT2062220056

Registered date:14/09/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: meniscus tear
• Date of first enrollment: 17/08/2022
• Target sample size: 8
• Study type: Interventional
• Intervention(s): P47K-WAS-MR dissolved in saline is placed at the suture site when the meniscus is sutured

Outcome(s)

• Primary Outcome: Number and frequency of adverse events and failures (by severity and causal relationship with the investigational device)

Secondary Outcome

1) Evaluation of suture fusion status and fusion failure rate at 12 weeks post-suture (arthroscopy)
2) Evaluation of suture fusion status and fusion failure rate at 12 weeks post-suture (MRI scan)
3) Progress, changes
4) Joint gap width before and at 12 weeks after suture
5) Assessment of pain over time by VAS
6) Patient-oriented quality of life/ADL scores (IKDC ,KOOS, Lysholm Score) over time
7) Activity assessment at 12 weeks post-cooperation using the Tegner Score

Key inclusion & exclusion criteria

• Age minimum: >= 8age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

Patients who meet all of the following selection criteria will be considered
1) Patients who are at least 8 years old and less than 60 years old at the time of obtaining consent
2) Patients whose written consent has been obtained from the patient.
If the patient is between 8 and 18 years old, written consent must be obtained from both the patient and a surrogate (parents (or person who has parental authority over the subject), guardian, or other equivalent person).
3) Patients diagnosed on MRI images as having a meniscus injury that includes a no-bleeding field (2/3 of the area from the medial margin of the meniscus), either alone or in conjunction with an anterior cruciate ligament injury.
4) Patients with limited knee range of motion due to mechanical symptoms (Catching), or fitting symptoms (Locking) resulting from meniscus injury
5) Patients whose pain does not improve despite conservative treatment with exercise therapy or analgesics

Exclude criteria

Patients who meet any of the following criteria will be excluded from the study
1) Patients with a BMI greater than 50 kg/m 2
2) Patient underwent total meniscectomy on the affected side
3) Patients within 1 year of ligament reconstruction or osteotomy to the affected knee
4) Patients who have received an intra-articular injection into the target knee within 2 months prior to obtaining consent
5) Diagnosed with osteoarthritis of the knee Patient
6) Patients with a knee deformity of more than 10 degree of internal or external rotation relative to normal (FTA 175 degree)
7) Patients with a history of autoimmune arthritis (rheumatoid arthritis, etc.), sepsis, gout, pseudogout, pyogenic arthritis, or secondary arthropathy
8) Patients diagnosed with diabetes mellitus and poor glycemic control (HbA1c > 7.8 or on insulin therapy)
9) Patients with serious illnesses (metastatic cancer of any type, autoimmune diseases, etc.) for which the chance of survival may be less than 2 years
10) Patients with a history of allergy to silk, anesthetics, or antiseptics used in this study
11) Patients who test positive for at least one of HBs antigen, HCV antibody, or HIV antigen/antibody
12) Patients taking the following prescription medications:.
Regular use of opioid analgesics, anticoagulants, corticosteroids, growth hormone, testosterone
13) Patients on pacemakers, neurostimulators, metal particles, stents, and clips used for implants
14) Pregnant or lactating women, and patients who are unable to consent to the use of an effective contraceptive method under medical supervision for up to 12 weeks (Visit 6)
15) Patients participating in another clinical trial or other clinical research/study within 6 months of last use of investigational drug or device
16) Other patients deemed inappropriate by the investigator/associate investigator

Related Information

• Primary Sponsor: Adachi Nobuo
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Sanyo Chemical Industries, ltd.