Geniculate Artery Embolization for Osteoarthritis: Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Geniculate Artery Embolization
- Conditions
- Osteo Arthritis Knee
- Sponsor
- University of Minnesota
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Safety as Assessed by Grade 3-4 Adverse events
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed Description
This is a single center, two-arm, open label, pilot study to assess feasibility and safety and obtain a preliminary estimate of efficacy of geniculate artery embolization in reducing pain compared to a control group undergoing conservative presurgical management. The 20 patients will be randomly divided into two groups of 10 in 1:1 allocation. One group will have embolization of the geniculate artery branches and standard of care while the other will have only the standard care. Following the completion of the 10 participants in each arm, a safety and data review will be undertaken (Visit 4 in the GAE group and Visit 2 of the SOC). The data will be assessed regarding the trends between the groups as they relate to KOOS/WOMAC pain scale, MRI / Xray evaluation of OA, and presence of inflammatory biomarkers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •BMI \>35 kg/m2
- •Advanced peripheral arterial disease (resting ABI \<= 0.9).
- •Known significant peripheral arterial disease precluding common femoral catheterization
- •Have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
- •Diabetics with hemoglobin A1C of \>9%
- •Previous lower extremity embolization
- •Uncontrolled emotional disorders per patient medical history
- •Chronic pain syndrome or currently under a pain contract.
- •Anatomic variants involving the lower extremities which would increase the risk of non-target embolization
- •Renal insufficiency based on an estimated GFR\<45 ml/min who are not already on hemodialysis.
Arms & Interventions
GAE + Standard of Care
Participants in this arm will receive geniculate artery embolization and standard of care.
Intervention: Geniculate Artery Embolization
Standard of Care
Participants in this arm will receive standard of care only.
Outcomes
Primary Outcomes
Safety as Assessed by Grade 3-4 Adverse events
Time Frame: 12 months
Safety will be reported using the combined number of grade 3 and 4 adverse events that occur in each arm.
Secondary Outcomes
- IL-6 Concentration(baseline, 1 month, 12 months)
- C-Reactive Protein Concentration(baseline, 1 month, 12 months)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)(baseline, 1 month, 6 months, 12 months)
- Prostaglandin E2 Concentration(baseline, 1 month, 12 months)
- Erythrocyte Sedimentation Rate(baseline, 1 month, 12 months)
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(baseline, 1 month, 6 months, 12 months)
- Matrix Metalloprotinase 1 Concentration(baseline, 1 month, 12 months)
- Vascular Endothelial Growth Factor Concentration(baseline, 1 month, 12 months)