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

NCT ID: NCT05917028

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-23
• Study Completion Date: 2025-12-31

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.

Detailed 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).

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcatheter Arterial Micro-Embolization

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

Group Type: EXPERIMENTAL

Transcatheter Arterial Micro-Embolization

Intervention Type: DEVICE

Participants will undergo TAME with Nexsphere-F.

Interventions

Transcatheter Arterial Micro-Embolization

Participants will undergo TAME with Nexsphere-F.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Next Biomedical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyuckmin Kwon

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Severance Hospital

Seoul, Seodaemun-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hyuckmin Kwon

Role: CONTACT

next@nextbiomedical.co.kr

+82-32-454-4800

Sungmo Moon

Role: CONTACT

next@nextbiomedical.co.kr

+82-32-454-4800

Facility Contacts

Hyuckmin Kwon

Role: primary

next@nextbiomedical.co.kr

+82-32-454-4800

Other Identifiers

NS-F TAME001

Identifier Type: -

Identifier Source: org_study_id