Investigator-initiated Clinical Trial to Evaluate the Safety and Efficacy of AX-1911, Magnetic Field Generator for Magnetic Targeting, in Knee Osteoarthritis

Kamei Naosuke0 sites5 target enrollmentOctober 5, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 5, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Kamei Naosuke

•1\) Patients whose age is between 20 and 80 years old at the time of obtaining consent
•2\) Patients whose written consent has been obtained
•3\) Patients who have been diagnosed with kneeosteoarthritis
•4\) Patients with Kellgren\-Lawrence classification grade 2 or 3 osteoarthritis on X\-ray examination
•5\) Patients whose articular cartilage damage is limited to the medial condyle or lateral condyle
•6\) Patients who have received conservative treatment, including exercise therapy, for at least 3 months from the time of enrollment
•7\) Patients with clinical symptoms of pain in the knee

•1\) Patients who have undergone reconstruction of the anterior cruciate ligament and/or posterior cruciate ligament within 2 months of enrollment in the study
•2\) Patients scheduled for treatment of meniscus injury or patients who have undergone surgery for meniscus injury within 6 months of enrollment in the study
•3\) Patients with knee deformity inward or outward more than 10 degrees from the normal value (FTA 175 degrees)
•4\) Patients with implanted medical devices that may be affected by magnetic fields
•5\) Patients with malignant tumors, suspected malignant tumors, or with a history of malignant tumors within 5 years
•6\) Patients who are pregnant or may be pregnant, who are breast\-feeding, or who wish to become pregnant during this study
•7\) Patients with psychiatric disorders
•8\) Patients with a history of hypersensitivity to ferucarbotran components or iron injection
•9\) Patients with iron overload such as hemochromatosis
•10\) Patients with active bleeding