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

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

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 Overview

• Status: Terminated
• Conditions: Osteoarthritis (OA) of the Knee
• Intervention / Treatment: Procedure: Genicular artery embolization; Procedure: Intra-articular injection with corticosteroids.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Yunlin
    • Douliu, Yunlin, Taiwan, 640
      • National Taiwan University Hosiptal Yunlin Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm: GAE (IPM/CS).; Genicular artery embolization with imipenem/cilastatin (IPM/CS).	Procedure: Genicular artery embolization; The patient will receive GAE procedure and sham IA procedure.
Active Comparator: Comparator: IA (corticosteroids); The patient will receive IA procedure and sham GAE procedure.	Procedure: Intra-articular injection with corticosteroids.; The patient will receive IA procedure and sham GAE procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Efficacy: numeric rating scale (NRS)	Maximum decreased of pain score (NRS)	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.	Pre-intervention, post-1, 3, 6, 12 months
Clinical Efficacy: Lequesne'Index	Lequesne index for knee osteoarthritis severity.	Pre-intervention, post-1, 3, 6, 12 months
Clinical Outcome: PGIC	Self-report measure Patient Global Impression of Change (PGIC).	Pre-intervention, post-1, 3, 6, 12 months
Clinical Outcome: Analgesic Usage and other Pain Control Treatments	Use of narcotics or non-steroidal anti-inflammatory drugs (NSAID's); other pain control treatments.	Pre-intervention, post-1, 3, 6, 12 months
Clinical Outcome: Quality of Life	EQ-5D-5L questionnaire	Pre-intervention, post-1, 3, 6, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Monitoring	The society of interventional radiology AE classification system, 2017 modification.	Pre-intervention, post-1, 3, 6, 12 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Taiwan University Hospital, Yun-Lin Branch

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Actual): October 2, 2025
• Study Completion (Actual): October 2, 2025

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: knee osteoarthritis; intra-articular corticosteroid injection; imipenem/cilastatin; genicular artery embolization
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenal Cortex Hormones
• Other Study ID Numbers: 202408153RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No