Geniculate Artery Embolization for Osteoarthritis (NCT04456569) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Geniculate Artery Embolization for Osteoarthritis
United States20 participantsStarted 2022-02-01
Plain-language 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.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Abnormal INR (\>1.5)
* Plat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.