Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis
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
Next Biomedical Co., Ltd.
20 participants
Oct 23, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 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.
Exclusion Criteria12
- 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
- A person who has undergone knee arthroplasty
- A person who has not had knee microfracture surgery for more than 10 years
- INR 2.5 or less than 30,000 platelets
- Anaphylaxis-causing iodine allergy
- Patients with renal dysfunction or impaired renal function who have been diagnosed with less than 45 GFR (eGFR) within the last 60 days
- Those who have a taboo on MR videos
- Pregnant women
- Other cases where it is deemed inappropriate to participate in this clinical trial at the discretion of the researcher
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Interventions
Participants will undergo TAME with Nexsphere-F.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05917028