Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0009065
- Lead Sponsor
- extbiomedical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Rate of WOMAC Score Reduction, 2) Rate of VAS Score
- Secondary Outcome Measures
Name Time Method 1) Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score), 2)The rate of reduction of medication,combination treatment