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

未提供0 个研究点目标入组 5 人开始时间: 2021年10月20日最近更新: 2024年8月6日

适应症

试验速览

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

•Patients who have undergone reconstruction of the anterior cruciate ligament and/or posterior cruciate ligament within 2 months of enrollment in the study
•Patients scheduled for treatment of meniscus injury or patients who have undergone surgery for meniscus injury within 6 months of enrollment in the study
•Patients with knee deformity inward or outward more than 10 degrees from the normal value (FTA 175 degrees)
•Patients with implanted medical devices that may be affected by magnetic fields
•Patients with malignant tumors, suspected malignant tumors, or with a history of malignant tumors within 5 years
•Patients who are pregnant or may be pregnant, who are breast-feeding, or who wish to become pregnant during this study
•Patients with psychiatric disorders
•Patients with a history of hypersensitivity to ferucarbotran components or iron injection
•Patients with iron overload such as hemochromatosis
•Patients with active bleeding
•Patients with allergy to animals (bovine or porcine)
•Patients with hypersensitivity to gentamicin or amphotericin B, and patients with a history of hypersensitivity to aminoglycoside antibiotics
•Patients who are positive for beef allergy test
•Patients who are positive for any of the following tests; HBs antigen test, HCV antibody test, or HIV antibody test
•Other patients who are judged by the investigator or sub-investigator to be inappropriate to participate in this study

Incidence rate of adverse events (%) and incidence rate of defects (%)

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发起方

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