- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04456569
Geniculate Artery Embolization for Osteoarthritis
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Connie Dale, MD
- Email: dalex179@umn.edu
Study Contact Backup
- Name: Allison Wolf, MPH
- Email: wolfx494@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Contact:
- Reza Talaie, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GAE + Standard of Care
Participants in this arm will receive geniculate artery embolization and standard of care.
|
All patients within the embolization group will undergo unilateral angiography and embolization of the appropriate treatment limb geniculate arteries.
For patients with bilateral disease the more clinically symptomatic side will be chosen as the treatment/control knee.
|
No Intervention: Standard of Care
Participants in this arm will receive standard of care only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: baseline, 1 month, 6 months, 12 months
|
The KOOS measures 5 patient-relevant dimensions, each scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). Items are rated on a 5-point Likert scale from 0 (No problems) to 4 (Extreme problems). Dimension scores are calculated as the mean score of the included items divided by 4 and multiplied by 100. Range of subscale scores is 0-100 with higher scores indicating better function. |
baseline, 1 month, 6 months, 12 months
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: baseline, 1 month, 6 months, 12 months
|
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), stiffness (2 items), and physical function (17 items).
Items are rated on a Likert scale of 0 (extreme) to 4 (none).
Raw sub-scale scores are normalized to produce percentage scores in accordance with the KOOS by multiplying each score by 100/96.
Total scores are a sum of the normalized sub-scales scores and range 0-100, with higher scores indicating better functioning.
|
baseline, 1 month, 6 months, 12 months
|
IL-6 Concentration
Time Frame: baseline, 1 month, 12 months
|
Interleukin-6 concentrations will be measured in the serum and joint aspirate and reported in units of pg/ml.
|
baseline, 1 month, 12 months
|
Prostaglandin E2 Concentration
Time Frame: baseline, 1 month, 12 months
|
Prostaglandin E2 concentrations will be measured in the serum and joint aspirate and reported in units of pg/ml.
|
baseline, 1 month, 12 months
|
Matrix Metalloprotinase 1 Concentration
Time Frame: baseline, 1 month, 12 months
|
Matrix Metalloprotinase 1 concentrations will be measured in the serum and joint aspirate and reported in units of ng/ml.
|
baseline, 1 month, 12 months
|
Vascular Endothelial Growth Factor Concentration
Time Frame: baseline, 1 month, 12 months
|
Vascular Endothelial Growth Factor concentrations will be measured in the serum and joint aspirate and reported in units of pg/ml.
|
baseline, 1 month, 12 months
|
C-Reactive Protein Concentration
Time Frame: baseline, 1 month, 12 months
|
C-Reactive Protein concentrations will be measured in the serum and reported in units of mg/L.
|
baseline, 1 month, 12 months
|
Erythrocyte Sedimentation Rate
Time Frame: baseline, 1 month, 12 months
|
Erythrocyte sedimentation rate will be performed using serum and reported in units of mm/hr.
|
baseline, 1 month, 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility as Assessed by Protocol Adherence
Time Frame: 12 months
|
Feasibility will be assessed and reported as the number of participants in each arm who drop out due to a lack of protocol adherence.
|
12 months
|
Feasibility as Assessed by Recruitment Rate
Time Frame: 12 months
|
Feasibility will be assessed and reported as the mean number of participants who are enrolled each month over the length of the study (12 months).
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Reza Talaie, MD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAD-2019-27368
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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