Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis

Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Double-Blind, Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.


Eligibility Criteria:
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