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

NCT06929585 | Terminated

• 1 other identifier: 202408153RIND
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

knee osteoarthritis; genicular artery embolization; imipenem/cilastatin; intra-articular corticosteroid injection

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint: numeric rating scale (NRS)

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

  Post-intervention 3 month.

Secondary Outcomes (6)

• Clinical Efficacy: numeric rating scale (NRS)

  In the one-year period after intervention.

• Clinical Efficacy: WOMAC

  Pre-intervention, post-1, 3, 6, 12 months

• Clinical Efficacy: Lequesne'Index

  Pre-intervention, post-1, 3, 6, 12 months

• Clinical Outcome: PGIC

  Pre-intervention, post-1, 3, 6, 12 months

• Clinical Outcome: Analgesic Usage and other Pain Control Treatments

  Pre-intervention, post-1, 3, 6, 12 months

Other Outcomes (1)

• Adverse Events Monitoring

  Pre-intervention, post-1, 3, 6, 12 months

Study Arms (2)

Experimental arm: GAE (IPM/CS).

EXPERIMENTAL

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

Procedure: Genicular artery embolization

Comparator: IA (corticosteroids)

ACTIVE COMPARATOR

The patient will receive IA procedure and sham GAE procedure.

Procedure: Intra-articular injection with corticosteroids.

Interventions

Genicular artery embolization PROCEDURE

The patient will receive GAE procedure and sham IA procedure.

Experimental arm: GAE (IPM/CS).

Intra-articular injection with corticosteroids. PROCEDURE

The patient will receive IA procedure and sham GAE procedure.

Comparator: IA (corticosteroids)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years
• Symptomatic knee pain, with numeric rating scale (NRS) ≥ 4.
• Insufficient or resistant to conservative treatment, including oral analgesics, physical therapy, intra-articular injections for at least 3 months, before the enrollment.
• Weight bearing X ray of knee: osteoarthritis of Kellgren-Lawrence grade 1, 2, or 3.

You may not qualify if:

• History of trauma in recent 6 months.
• Bleeding tendency.
• Poor renal function (serum creatinine \> 2.0 mg/dL).
• Pregnancy or breast-feeding.
• Severe peripheral arterial occlusive disease (PAOD).
• Local infections or inflammatory arthritis of knee.
• Rheumatoid arthritis or other rheumatological diseases.
• Prior knee surgeries (arthroscopic surgery, menisci repair, cruciate ligament reconstruction, arthroplasty of knee) due to knee pain.
• Malignancy
• ECOG \> grade 2
• Life expectancy less than 2 years.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital, Yun-Lin Branch: collaborator

Study Sites (1)

National Taiwan University Hosiptal Yunlin Branch

Douliu, Yunlin, 640, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: March 25, 2025
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)