Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis

Last updated: March 27, 2025
Sponsor: Next Biomedical Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

Transcatheter Arterial Micro-Embolization

Clinical Study ID

NCT05917028
NS-F TAME001
  • Ages > 50
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Those who fall under Kellgren-Lawrence grade 2 to 3 according to the criteria inaccordance 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 andrehabilitation exercises, and joint injections of hyaluronic acid for more than 12weeks

  • A person who agrees to maintain existing medication treatments during the clinicaltrial period but does not receive additional medication or new conservativetreatments for knee osteoarthritis pain management.

Exclusion

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 toatherosclerosis 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 diagnosedwith 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 trialat the discretion of the researcher

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Transcatheter Arterial Micro-Embolization
Phase:
Study Start date:
October 23, 2023
Estimated Completion Date:
December 31, 2025

Study Description

This clinical trial is a single arm, single center, open label, and pilot clinical trial to prove the performance and safety of Nexsphere-F in patients over the age of 50 who need additional treatment because pain is not controlled even after conventional treatments are taken.

Since consent cannot be obtained during surgery from a subject who meets the inclusion and exclusion criteria, a written consent is obtained in advance between four weeks before the procedure and the day. As one of the usual orthopedic evaluations, baseline MRI will be performed and WORMS will be evaluated. In addition, the WOMAC score and the VAS score will be measured before the procedure and used as a baseline for evaluation variables. Since it is a pilot study to evaluate the validity, all subjects will undergo a Transcatheter Arterial Micro-Embolization (TAME).

Connect with a study center

  • Severance Hospital

    Seoul, Seodaemun-gu 03722
    Korea, Republic of

    Active - Recruiting

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