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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917028
• Other study ID #: NS-F TAME001
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Next Biomedical Co., Ltd.
• Contact: Min Jung
• Phone: +82-32-454-4800
• Email: next[@]nextbiomedical.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Transcatheter Arterial Micro-Embolization
Participants will undergo TAME with Nexsphere-F.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Seodaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
Next Biomedical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	The rate of reduction of medication	The rate of change of medication before and after application of medical devices for clinical trials.	6 months
Secondary	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