This is a single center phase I and II study which is designed to initially assess the safety, and later the efficacy of geniculate artery embolization in reducing pain compared to a control group undergoing only conservative presurgical management.
This study will consist of two phases, each with a 1 month preprocedural evaluation, day of treatment and 30 day follow up period for the first 10 participants and 6 month for the remaining 40 participants. 10 participants will be enrolled for the first phase, and 40 participants will be enrolled for the second phase at the University of Minnesota Medical Center.
Enrollment is expected to take up to 6 months for each phase of the study. The collection of data will be accomplished by utilizing a clinical research team that will assess the efficacy and safety. Efficacy assessments will include; Joint injection intervals, MRI, X-ray, joint aspiration / serologies and patient questionnaires evaluating joint pain. Safety assessments include participant and investigator reported adverse events, vital signs, (blood pressure, heart rate, temperature), and physical exam.
Unilaterally dominant symptomatic osteoarthritis (bilateral radiographic OA will not exclude)
Patients who are symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or 0-1 intra-articular injections of the affected knee)
Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
Patients who are willing to comply with the protocol requirements and willing to undergo non-contrast MRI 1-30 days prior to procedure and at 12 months following procedure
Patients who are willing to comply with regular follow up during the 12 month follow-up period
Patients who have been evaluated by an orthopaedic surgeon or sports medicine provider and deemed to not be a current candidate for partial or total knee arthroplasty. These patients do, however, need to be considered a potential candidate for partial or total knee as an end point following the natural history of osteoarthritis.
Patients with WOMAC Score >=6 in at least 2 categories
Patients with a weight >250 pounds
Patients with advanced peripheral arterial disease (resting ABI <= 0.9)
Patients with known significant peripheral arterial disease precluding common femoral catheterization
Patients who do smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
Patients with diabetes who have a hemoglobin A1C of >9%
Patients who have undergone previous lower extremity embolization
Patients with uncontrolled emotional disorders per patient medical history
Patients with chronic pain syndrome or currently under a pain contract
Patients with anatomic variants involving the lower extremities which would increase the risk of non-target embolization
Patients with renal insufficiency based on an estimated GFR<45 ml/min who are not already on hemodialysis.
Patients with an abnormal INR (>1.5).
Patients with a platelet count <50x109/L.
Patients who are currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure.
Patients with a known severe allergy to iodine which cannot be adequately pre-medicated
Patients who are pregnant or intend to become pregnant within 6 months of the procedure
Patients with a contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl
Patients with a life expectancy <60 months
Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
Patients with contraindications to medical and physical rehabilitative treatments of OA
Patients with known advanced atherosclerosis
Patients with known current or previous lower extremity fistula
Patients with rheumatoid arthritis or seronegative arthropathies
Patients with prior ipsilateral knee surgery.
Patients with WOMAC Pain Scale < 6
Patients having received more than one steroid injection in the affected joint or an injection in the affected joint within 3 months of screening