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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Transcatheter Arterial Micro-Embolization

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).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Jung; Phone Number: +82-32-454-4800; Email: next@nextbiomedical.co.kr
• Study Contact Backup: Name: Sungmo Moon; Phone Number: +82-32-454-4800; Email: next@nextbiomedical.co.kr

Study Locations

• Korea, Republic of
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, Korea, Republic of, 03722
      • Recruiting
      • Severance Hospital
      • Contact: Min Jung; Phone Number: +82-32-454-4800; Email: next@nextbiomedical.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 allow existing drug treatment during the clinical trial, but not to be subject to additional drug administration or new conservative treatment for symptom control

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
• Who had previous knee surgery
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter Arterial Micro-Embolization; If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F.	Device: Transcatheter Arterial Micro-Embolization; Participants will undergo TAME with Nexsphere-F.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)	The rate of change of WORMS before and after application of medical devices for clinical trials. MRI images of cartilage, marrow abnormality, bone cysts, bone attrition, ostephytes, menisci, ligaments, and synovitis are scored and recorded.	1 month
The rate of reduction of medication	The rate of change of medication before and after application of medical devices for clinical trials.	6 months
The rate of discontinuation of combination treatment	The rate of change of combination treatment before and after application of medical devices for clinical trials.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with abnormal cases during follow-up (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia)	Abnormal cases that occurred after the application of medical devices for clinical trials (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia)	1 day, 14 days, 1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Next Biomedical Co., Ltd.
• Investigators: Principal Investigator: Min Jung, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: NS-F TAME001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No