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

National Taiwan University

Status: Terminated

Conditions: Osteoarthritis (OA) of the Knee

Treatments: Procedure: Genicular artery embolization; Procedure: Intra-articular injection with corticosteroids.

Study type: Interventional

Funder types: Other

Identifiers

NCT06929585

202408153RIND

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Experimental arm: GAE (IPM/CS).

Experimental group

Description:

Genicular artery embolization with imipenem/cilastatin (IPM/CS).

Treatment:

Procedure: Genicular artery embolization

Comparator: IA (corticosteroids)

Active Comparator group

Description:

The patient will receive IA procedure and sham GAE procedure.

Treatment:

Procedure: Intra-articular injection with corticosteroids.