Genicular Artery Embolization (GAE) vs inTra-articular Corticosteroid Injection for Osteoarthritic Knee Pain.

National Taiwan University Hospital1 enrolled

Overview

This study investigates genicular artery embolization (GAE) as a minimally invasive alternative to ntra-articular corticosteroid injections (IA) or treating knee osteoarthritis (OA) pain. Designed as a randomized controlled tria, the study compares pain relief effectiveness and safety between GAE and IA over a 12-month follow-up. Eligible participants are aged over 40 with symptomatic knee OA resistant to conservative treatment. Primary outcomes focus on pain reduction (NRS score), while secondary measures include function, quality of life, imaging findings, and adverse events.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis (OA) of the Knee

Interventions

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 40 years 2. Symptomatic knee pain, with numeric rating scale (NRS) ≥ 4. 3. Insufficient or resistant to conservative treatment, including oral analgesics, physical therapy, intra-articular injections for at least 3 months, before the enrollment. 4. Weight bearing X ray of knee: osteoarthritis of Kellgren-Lawrence grade 1, 2, or 3. Exclusion Criteria: 1. History of trauma in recent 6 months. 2. Bleeding tendency. 3. Poor renal function (serum creatinine \> 2.0 mg/dL). 4. Pregnancy or breast-feeding. 5. Severe peripheral arterial occlusive disease (PAOD). 6. Local infections or inflammatory arthritis of knee. 7. Rheumatoid arthritis or other rheumatological diseases. 8. Prior knee surgeries (arthroscopic surgery, menisci repair, cruciate ligament reconstruction, arthroplasty of knee) due to knee pain. 9. Malignancy 10. ECOG \> grade 2 11. Life expectancy less than 2 years. 12. Any other condition related to the patient's health, regarded exclusionary in the opinion of the investigator.

Outcomes

Primary Outcomes

Primary Efficacy Endpoint: numeric rating scale (NRS)

Changes of pain score (NRS) at the 3-month compared with the baseline.

Time frame: Post-intervention 3 month.

Secondary Outcomes

Clinical Efficacy: numeric rating scale (NRS)

Maximum decreased of pain score (NRS)

Time frame: In the one-year period after intervention.

Clinical Efficacy: WOMAC

Western Ontario and McMaster Universities Arthritis Index (WOMAC) \*Clinical success defined as ≥ 40% improvement of the WOMAC score.