Clinical trial NCT06929585: Genicular Artery Embolization (GAE) vs inTra-articular Corticosteroid Injection for Osteoarthritic Knee Pain.
Official title: Genicular Artery Embolization (GAE) vs inTra-articular Corticosteroid Injection for Osteoarthritic Knee Pain. (GET-IN Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
Keywords: knee osteoarthritis
genicular artery embolization
imipenem/cilastatin
intra-articular corticosteroid injection
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital, Yun-Lin Branch
First posted: 2025-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Primary Efficacy Endpoint: numeric rating scale (NRS)
timeFrame: Post-intervention 3 month.
Secondary outcomes:
measure: Clinical Efficacy: numeric rating scale (NRS)
timeFrame: In the one-year period after intervention.
measure: Clinical Efficacy: WOMAC
timeFrame: Pre-intervention, post-1, 3, 6, 12 months
measure: Clinical Efficacy: Lequesne'Index
timeFrame: Pre-intervention, post-1, 3, 6, 12 months
measure: Clinical Outcome: PGIC
timeFrame: Pre-intervention, post-1, 3, 6, 12 months
measure: Clinical Outcome: Analgesic Usage and other Pain Control Treatments
timeFrame: Pre-intervention, post-1, 3, 6, 12 months
measure: Clinical Outcome: Quality of Life
timeFrame: Pre-intervention, post-1, 3, 6, 12 months
Other outcomes:
measure: Adverse Events Monitoring
timeFrame: Pre-intervention, post-1, 3, 6, 12 months
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan University Hosiptal Yunlin Branch
state: Yunlin
Study officials:
References: