Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

NCT ID: NCT04472091

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2026-11-01

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.

Conditions

Knee Osteoarthritis; Knee Pain Chronic; Knee Pain Swelling; Knee Arthritis; Arterial Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genicular artery embolization

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.

Group Type: EXPERIMENTAL

Genicular artery embolization (GAE)

Intervention Type: DEVICE

Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).

Interventions

Genicular artery embolization (GAE)

Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).

Intervention Type: DEVICE

Eligibility Criteria

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

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

Sponsors

Andrew Picel

OTHER

Sponsor Role: lead

Responsible Party

Andrew Picel

Assistant Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrew C Picel, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

IDE G200111

Identifier Type: OTHER

Identifier Source: secondary_id

57046

Identifier Type: -

Identifier Source: org_study_id