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

NCT ID: NCT06929585

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2025-10-02

Brief Summary

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.

Conditions

Osteoarthritis (OA) of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental arm: GAE (IPM/CS).

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

Group Type: EXPERIMENTAL

Genicular artery embolization

Intervention Type: PROCEDURE

The patient will receive GAE procedure and sham IA procedure.

Comparator: IA (corticosteroids)

The patient will receive IA procedure and sham GAE procedure.

Group Type: ACTIVE_COMPARATOR

Intra-articular injection with corticosteroids.

Intervention Type: PROCEDURE

The patient will receive IA procedure and sham GAE procedure.

Interventions

Genicular artery embolization

The patient will receive GAE procedure and sham IA procedure.

Intervention Type: PROCEDURE

Intra-articular injection with corticosteroids.

The patient will receive IA procedure and sham GAE procedure.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital, Yun-Lin Branch

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hosiptal Yunlin Branch

Douliu, Yunlin, Taiwan

Countries

Taiwan

Other Identifiers

202408153RIND

Identifier Type: -

Identifier Source: org_study_id