Using Nexsphere-F to treat knee osteoarthritis pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of Transcatheter Arterial Micro-Embolization (TAME) using Nexsphere-F in patients aged 50 and older with knee degenerative osteoarthritis. It targets individuals whose pain remains uncontrolled despite conventional treatments. The study is a single-arm, open-label pilot trial conducted at a single center, where participants will undergo TAME and have their pain assessed using various scoring systems before and after the procedure. Written consent is obtained prior to the procedure, and baseline evaluations include MRI and pain scoring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Severance Hospital
  Seoul, Seodaemun-gu, South Korea Recruiting

Study contacts

• Principal investigator: Hyuckmin Kwon — Severance Hospital
• Study coordinator: Hyuckmin Kwon
• Email: next@nextbiomedical.co.kr
• Phone: +82-32-454-4800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.