A comparative, randomized clinical trial to evaluate the efficacy and safety of genicular artery embolization in patients with knee osteoarthritis who continue to experience pain despite more than three months of treatment, compared to conservative therapy.

A single-center, prospective, randomized, superiority, pivotal clinical trial to evaluate the efficacy and safety of transcatheter arterial embolization using ‘KIPZA’ compared with conservative treatment for patients with knee osteoarthritis whose pain persists despite conservative treatment for more than 3 months

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012208

Enrollment

Registered

2026-07-01

Start date

2025-01-07

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : 1. Patients with knee osteoarthritis whose pain persists despite =3 months of conservative treatment will be referred for potential participation in this clinical t

therefore, no specific intervention may be performed at baseline (Visit 2) for the control arm. 5. (Experimental arm only) After completion of the TAE procedure, participants will be observed until ho

however, the timing of admission and discharge is at the investigator’s discretion. 6. At Day 1, Week 4, Week 12, and Week 24 post-baseline (Visits 3–6), participants will return to the study site for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Individuals aged 19 years or older. 2. Individuals who have experienced moderate or greater pain (VAS > 50 mm) persisting for more than 3 months despite conservative treatment. 3.Individuals who agree not to receive any conservative treatment other than those permitted in this clinical study (physical therapy, pharmacologic therapy [NSAIDs, opioid analgesics, acetaminophen, SYSADOA agents, muscle relaxants], or intra-articular injections [hyaluronic acid, polynucleotide]). 4. Individuals with Kellgren–Lawrence (K-L) grade 1 to 3. 5. Individuals who voluntarily decide to participate in this clinical study and provide written informed consent after receiving adequate explanation. 6. Individuals who are willing and able to comply with the study protocol.

Exclusion criteria

Exclusion criteria: Individuals who meet any of the following criteria will be excluded from participation in this clinical study: 1. History of knee surgery in the target lower extremity prior to screening. 2. Individuals who meet any of the following conditions and are considered inappropriate candidates for TAE (transarterial embolization), or who fall under contraindications for the study device: - Rheumatoid arthritis - Advanced atherosclerosis - Presence or anticipated occurrence of vasospasm - Glomerular filtration rate (GFR) < 45 mL/min - Hemorrhagic disorders or coagulopathies (e.g., idiopathic thrombocytopenic purpura, hemophilia, disseminated intravascular coagulation) - Local infection in the target lower extremity or systemic infection (e.g., sepsis) - Anatomical conditions that make catheter insertion into the target artery impossible 3. Individuals currently undergoing anticancer therapy or with a history of malignancy within the past 5 years (Individuals with a history of adequately treated basal cell or squamous cell skin cancer, or noninvasive carcinomas, may be eligible at the investigator’s discretion.) 4. History of hypersensitivity to gelatin. 5. History of hypersensitivity to contrast media. 6. Individuals with contraindications to MRI examinations (e.g., metallic implants in the body). 7. Pregnant or breastfeeding women. 8. Women of childbearing potential who do not agree to use medically acceptable contraception during the study period, including: Hormonal contraception, intrauterine device (IUD) or intrauterine system (IUS), tubal ligation, dual barrier methods (male condom, female condom, cervical cap, diaphragm, contraceptive sponge), or single barrier methods combined with spermicides. 9. Individuals currently participating in another clinical trial or who have participated in another trial within 30 days prior to the screening date. 10. Any other condition that, in the investigator’s judgment, would make the individual unsuitable for participation due to ethical concerns or potential impact on study outcomes.

Design outcomes

Primary

Measure	Time frame
Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain score from baseline	—

Secondary

Measure	Time frame
Change in the WOMAC Pain score from baseline to;Change in the WOMAC-total score from baseline;Change in the visual analog scale (VAS) score (mm) from screening;Change in the whole-organ magnetic resonance imaging score (WORMS) from screening;Adverse Event (AE)	—

Countries

Korea, Republic of

Contacts

Public ContactJi Yeong Kang

Konkuk University Medical Center

2024c006@kuh.ac.kr+82-2-2030-5114

Outcome results