Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT05917028

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

Led by Next Biomedical Co., Ltd. · Updated on 2025-04-02

20

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 50 years or older
  • Kellgren-Lawrence grade 2 to 3 knee osteoarthritis based on X-ray within last 12 months
  • Visual Analog Scale (VAS) pain score above 50mm
  • Ongoing treatment with glucosamine chondroitin sulfate, rehabilitation exercises, or hyaluronic acid joint injections for at least 12 weeks
  • Agreement to maintain existing medications during the study without adding new treatments for knee osteoarthritis pain
Not Eligible

You will not qualify if you...

  • Local infection
  • Life expectancy less than six months
  • Symptoms of lower extremity vascular disease such as claudication or ischemic rest pain
  • Diagnosis of rheumatism or infectious arthritis
  • History of knee arthroplasty
  • Knee microfracture surgery within the past 10 years
  • INR greater than 2.5 or platelet count below 30,000
  • Allergy causing anaphylaxis to iodine
  • Renal dysfunction with eGFR less than 45 within last 60 days
  • Contraindication to MRI
  • Pregnancy
  • Any condition deemed inappropriate for participation by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Severance Hospital

Seoul, Seodaemun-gu, South Korea, 03722

Actively Recruiting

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Research Team

H

Hyuckmin Kwon

CONTACT

S

Sungmo Moon

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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