Among knee degenerative osteoarthritis patients aged 50 or older, it will prove the therapeutic effect and safety of Nexsphere-F embolization for patients who need additional treatment because pain is not controlled even if conventional treatments are taken.
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
VAS score exceeding 50mm
An adult male and female over 50 years of age
Preservative therapy Glucosamine chondroitin sulfate/physiological therapy and rehabilitation exercises, and joint injections of hyaluronic acid for more than 12 weeks
A locally infected patient
A person whose life expectancy is less than six months
A person with symptoms of lower extremities that are considered secondary to atherosclerosis or arterial vascular disease (ex: claudication ischemic rest pain)
A person diagnosed with rheumatism or infectious arthritis
Single group
Transcatheter Arterial Micro-Embolization
DeviceParticipants will undergo TAME with Nexsphere-F.
Rate of WOMAC Score Reduction
The rate of change of WOMAC Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.
Rate of VAS Score (patient pain intensity) Reduction
The rate of change of VAS Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.
Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)
The rate of change of WORMS before and after application of medical devices for clinical trials. MRI images of cartilage, marrow abnormality, bone cysts, bone attrition, ostephytes, menisci, ligaments, and synovitis are scored and recorded.
The rate of reduction of medication
The rate of change of medication before and after application of medical devices for clinical trials.
The rate of discontinuation of combination treatment
The rate of change of combination treatment before and after application of medical devices for clinical trials.
Number of participants with abnormal cases during follow-up (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia)
Abnormal cases that occurred after the application of medical devices for clinical trials (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia)
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