Using Nexsphere-F to treat knee osteoarthritis pain
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
This study is testing a new treatment called Nexsphere-F to see if it can help relieve knee pain in people aged 50 and older who haven’t found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Next Biomedical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul, Seodaemun-gu) |
| Trial ID | NCT05917028 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 50 with Kellgren-Lawrence grade 2 to 3 osteoarthritis and a VAS pain score exceeding 50mm.
Not a fit: Patients with infections, severe vascular disease, or those with a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief for patients suffering from knee osteoarthritis who have not responded to standard therapies.
How similar studies have performed: While this approach is novel, similar studies exploring embolization techniques for pain management have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul, Seodaemun-gu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.