Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

Andrew Picel

Status: Withdrawn

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

Treatments: Device: Genicular artery embolization (GAE)

Study type: Interventional

Funder types: Other

Identifiers

NCT04472091

IDE G200111 (Other Identifier)

57046

Details and patient eligibility

About

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.

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Genicular artery embolization

Experimental group

Description:

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.

Treatment:

Device: Genicular artery embolization (GAE)