Geniculate Artery Embolization for Osteoarthritis: Pilot Study
The need for exploration of more definitive and cost effective non-arthroplasty treatments of osteoarthritis (OA) has been demonstrated by the orthopedic and health economic research. Embolotherapy of neovessels associated with OA joints has been shown to be promising in patients with knee OA. There is a need for level one evidence drawn from randomized clinical trials to prove the safety, feasibility and efficacy of knee embolotherapy compared to standard of care. This randomized pilot study will assign 10 patients with mild-moderate OA to undergo geniculate artery embolization plus standard of care (defined in this study as: physical therapy and oral anti-inflammatory medications, with a maximum of 1 joint injection at the time of enrollment) and 10 patients to receive only medical standard of care (also having had a maximum of 1 joint injection prior to enrollment). The goal of this pilot study is to obtain preliminary estimates of safety and efficacy of embolotherapy to provide sustained symptom control and modify disease progression in patients with mild to moderate knee OA.
• Between 40 - 70 years of age.
• Unilaterally dominant symptomatic OA (bilateral radiographic OA will not exclude).
• 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 intra-articular injections of the affected knee in the last 3 months).
• Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
• Willing to comply with the protocol requirements and willing to undergo non- contrast MRI during screening and at 12 months.
• Willing to comply with regular follow up during the 12 month follow-up period.
• Not a current candidate for partial or total knee arthroplasty.
• WOMAC Score \>=6 in at least 2 categories.