Clinical trial NCT04456569: Geniculate Artery Embolization for Osteoarthritis
Official title: Geniculate Artery Embolization for Osteoarthritis: Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Arthritis
Osteoarthritis
Osteoarthritis, Knee
Keywords: Embolotherapy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety as Assessed by Grade 3-4 Adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: baseline, 1 month, 6 months, 12 months
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: baseline, 1 month, 6 months, 12 months
measure: IL-6 Concentration
timeFrame: baseline, 1 month, 12 months
measure: Prostaglandin E2 Concentration
timeFrame: baseline, 1 month, 12 months
measure: Matrix Metalloprotinase 1 Concentration
timeFrame: baseline, 1 month, 12 months
measure: Vascular Endothelial Growth Factor Concentration
timeFrame: baseline, 1 month, 12 months
measure: C-Reactive Protein Concentration
timeFrame: baseline, 1 month, 12 months
measure: Erythrocyte Sedimentation Rate
timeFrame: baseline, 1 month, 12 months
Other outcomes:
measure: Feasibility as Assessed by Protocol Adherence
timeFrame: 12 months
measure: Feasibility as Assessed by Recruitment Rate
timeFrame: 12 months
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Reza Talaie, MD
role: PRINCIPAL_INVESTIGATOR
References: