Clinical trial NCT05917028: Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Next Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Rate of WOMAC Score Reduction
timeFrame: 1 day, 14 days, 1 month, 3 months, 6 months
measure: Rate of VAS Score (patient pain intensity) Reduction
timeFrame: 1 day, 14 days, 1 month, 3 months, 6 months
Secondary outcomes:
measure: Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)
timeFrame: 1 month
measure: The rate of reduction of medication
timeFrame: 6 months
measure: The rate of discontinuation of combination treatment
timeFrame: 6 months
Other outcomes:
measure: Number of participants with abnormal cases during follow-up (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia)
timeFrame: 1 day, 14 days, 1 month, 3 months, 6 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu
Study officials:
affiliation: Severance Hospital
name: Hyuckmin Kwon
role: PRINCIPAL_INVESTIGATOR
References: