Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

Not Applicable

Withdrawn

• Conditions: Knee Arthritis; Arterial Occlusion; Knee Osteoarthritis; Knee Pain Swelling; Knee Pain Chronic
• Interventions: Device: Genicular artery embolization (GAE)

• Registration Number: NCT04472091
• Lead Sponsor: Andrew Picel

Brief Summary

The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order to evaluate the effect on knee pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-15
• Study Start: 2025-01-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Provide informed consent

2. Age ≥ 40 years

3. Moderate to severe knee pain (VAS >40 mm)

4. Pain refractory to 3 months of conservative treatments, including at least one of the following:

   • a. Anti-inflammatory medications
   • b. Physical therapy
   • c. Intra-articular injections

5. Kellgren-Lawrence radiographic grade 1, 2, or 3 disease

6. MRI features of active synovitis (synovial thickening and/or enhancement on MRI).

7. Ineligibility or refusal of surgical management.

8. Local knee tenderness

Exclusion Criteria

1. Rheumatoid or infectious arthritis
2. Advanced lower extremity atherosclerosis that would limit selective angiography
3. Local knee infection
4. Prior knee surgery (excluding arthroscopic/meniscal interventions)
5. Uncorrectable coagulopathy (INR>1.8, platelets<50,000/µL)
6. Iodine allergy resulting in anaphylaxis
7. Chronic renal insufficiency (serum creatinine >2 mg/dL)
8. Life expectancy less than 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genicular artery embolization	Genicular artery embolization (GAE)	Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment related adverse events	24 months post GAE	Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline pain scores	Baseline 24 months post GAE	Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents "no pain" and 100 mm represents "worse possible pain."
Mean change from baseline knee function scores	Baseline to 24 months post GAE	Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of "0" indicates no symptoms and "4" indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States