A Single arm, Single center, Open label, Pilot Clinical Study to Evaluate the Efficacy and Safety of Transcatheter Arterial Micro-Embolization (TAME) using Nexsphere-F in Patients with Knee Degenerative Osteoarthritis

extbiomedical0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年6月24日

适应症

试验速览

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•1) Those who fall under Kellgren-Lawrence grade 2 to 3 according to the criteria in accordance with ACR guidelines and X-ray findings used within 12 months
•2) VAS score exceeding 50mm
•3) An adult male and female over 50 years of age
•4) Preservative therapy Glucosamine chondroitin sulfate/physiological therapy and rehabilitation exercises, and joint injections of hyaluronic acid for more than 12 weeks
•5) A person who agrees to maintain existing medication treatments during the clinical trial period but does not receive additional medication or new conservative treatments for knee osteoarthritis pain management.

•1) A locally infected patient
•2) A person whose life expectancy is less than six months
•3) A person with symptoms of lower extremities that are considered secondary to atherosclerosis or arterial vascular disease (ex: claudication ischemic rest pain)
•4) A person diagnosed with rheumatism or infectious arthritis
•5) A person who has undergone knee arthroplasty
•6) A person who has not had knee microfracture surgery for more than 10 years
•7) INR 2.5 or less than 30,000 platelets
•8) Anaphylaxis-causing iodine allergy
•9) Patients with renal dysfunction or impaired renal function who have been diagnosed with less than 45 GFR (eGFR) within the last 60 days
•10) Those who have a taboo on MR videos
•11) Pregnant women
•12) Other cases where it is deemed inappropriate to participate in this clinical trial at the discretion of the researcher

发起方

extbiomedical