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

NCT05917028 | Recruiting

• 1 other identifier: NS-F TAME001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Rate of WOMAC Score Reduction

  The rate of change of WOMAC Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.

  1 day, 14 days, 1 month, 3 months, 6 months

• Rate of VAS Score (patient pain intensity) Reduction

  The rate of change of VAS Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.

  1 day, 14 days, 1 month, 3 months, 6 months

Secondary Outcomes (3)

• Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)

  1 month

• The rate of reduction of medication

  6 months

• The rate of discontinuation of combination treatment

  6 months

Other Outcomes (1)

• Number of participants with abnormal cases during follow-up (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia)

  1 day, 14 days, 1 month, 3 months, 6 months

Study Arms (1)

Transcatheter Arterial Micro-Embolization

EXPERIMENTAL

If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F.

Device: Transcatheter Arterial Micro-Embolization

Interventions

Transcatheter Arterial Micro-Embolization DEVICE

Participants will undergo TAME with Nexsphere-F.

Transcatheter Arterial Micro-Embolization

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Next Biomedical Co., Ltd.: lead

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hyuckmin Kwon

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyuckmin Kwon

CONTACT

+82-32-454-4800; next@nextbiomedical.co.kr

Sungmo Moon

CONTACT

+82-32-454-4800; next@nextbiomedical.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 23, 2023
• Study Start: October 23, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)