Geniculate Artery Embolization for Osteoarthritis

Launched by UNIVERSITY OF MINNESOTA · Jun 29, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called geniculate artery embolization, which is being tested as a new treatment for people with mild to moderate knee osteoarthritis (OA). The goal is to see if this procedure can help relieve pain and slow down the progression of OA compared to standard treatments, which usually include physical therapy and anti-inflammatory medications. In this study, 20 participants will be divided into two groups: one group will receive the embolization procedure along with their usual treatments, while the other group will receive only the standard medical care.

To be eligible for this trial, participants need to be experiencing knee pain from osteoarthritis for at least three months and must not be candidates for knee surgery. They should also be willing to undergo an MRI and attend follow-up appointments for a year. If you think you or someone you know might qualify, this trial is currently recruiting participants. This study aims to provide important information about the safety and effectiveness of this new treatment option for knee OA.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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