Clinical Trial Finder

Inclusion Criteria:

• - Patients aged 40-80.

• - Bilateral or unilateral knee pain attributed to osteoarthritis.

• - Grade 2-4 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale.

• - Knee pain >6 months refractory to conservative, nonoperative medical management, as measured to be ≥ 4 on VAS (i.e. rest, activity modification, weight control, bracing, physical therapy under the supervision of a physical therapist for a prescribed protocol, NSAIDs, acetaminophen, oral opiate pain medicines, intra-articular injections of hyaluronic acid preparations, intra-articular injections of PRP, intra-articular injections of stem cells, and/or oral/injectable corticosteroids.

• - Refusal of intra-articular corticosteroid injection.

• - Refusal or ineligible for surgery.

Exclusion Criteria:

• - Active malignancy.

• - Active infection of the affected knee.

• - Corticosteroid injection of the affected knee within 3 months of enrollment.

• - Rheumatoid arthritis or other seronegative arthropathy.

• - Previous surgery of the affected knee (i.e. meniscus repair, meniscectomy, ACL reconstruction, PCL reconstruction, chondroplasty, microfracture, loose body removal, synovectomy, lateral release, patellar tendon repair, quadriceps tendon repair, total knee replacement, partial knee replacement, osteotomy, cartilage transplant), with the exception of diagnostic arthroscopy.

• - Grade 1 per Kellgren-Lawrence Grading Scale of the affected knee.

• - Pregnancy or expected pregnancy.

• - GFR <60.

• - Anaphylactic reaction to iodinated contrast.

• - Moderate to severe pain in other lower limb joints.

• - Body weight >400 lbs.

(prohibiting safe angiography)

• - Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater) - Subject with Type 1 diabetes mellitus.

• - Subjects with long-acting corticosteroid use within 6-months.

• - Subjects with history or other evidence of AKI.

• - Subjects with history of reaction to contrast media, bronchial asthma, and allergic disorders.

• - Subjects with history of hypersensitivity reactions to gadolinium-based contrast agents (GBCAs) - Chronic widespread pain, including neuropathic pain.

• - History of major depressive disorder within 2 years before screening.

• - Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) - History of suicide attempt/suicidal behaviour within 30 days before screening.

• - Patients with fibromyalgia.

- Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's safety or compliance with the protocol

Arms

Experimental: GAE Arm

In this study, GAE is performed using the Lipiojoint technique described by Sapoval et al. This method utilizes a 3:1 emulsion of Lipiodol® (a transient embolic agent that penetrates distally to about 30 microns) and Optiray® to target the genicular arteries supplying areas of synovial hypervascularity and neo-angiogenesis. The embolic effect is temporary-lasting roughly 10 minutes-after which angiographic imaging shows resolution of the embolization with no damage to the surrounding skin, tendon, or bone. The endpoint of the procedure is to achieve complete stasis in the targeted vessels. 20 participants will be randomly allocated to this arm.

Sham Comparator: Sham Arm

Participants assigned to the sham group undergo a similar preparatory process, including angiography and catheterization of all genicular arteries. However, no embolic agent is administered. Instead, after performing selective angiograms, these participants do not receive any embolization. 20 participants will be randomly allocated to this arm.

Interventions

Procedure: - Genicular Artery Embolization

Embolization of genicular arteries that demonstrate neoangiogenesis or blush on angiogram.

Device: - Lipiodol

3:1 emulsion of Lipiodol to Optiray

Procedure: - Simple angiogram

Simple angiogram of the genicular arteries