No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
46 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for adults with knee osteoarthritis who are in moderate to severe pain and are considering a specific procedure called genicular artery embolization (GAE). Participants will have MRIs and answer some questions before and after the procedure to see how it helps their condition.
I plan to have genicular artery embolization for my knee osteoarthritis.
I have been diagnosed with knee osteoarthritis in the last 6 months.
I have had persistent moderate to severe knee pain for at least 6 months.
My pain has not improved with usual treatments.
My BMI is less than 35.
I am willing to follow study procedures.
You may not be able to join if
I have a serious bleeding disorder.
I take blood thinner medications that can't be paused for the procedure.
I am allergic to certain contrast agents and cannot take steroids beforehand.
I have an active infection in my knee joint.
I have had surgery due to a recent knee injury.
I have had a knee replacement in the past.
I had a steroid injection in my knee within the last 2 months.
I have a serious medical condition that affects my life expectancy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this clinical trial is to learn if genicular artery embolization (GAE) can improve knee pain and decrease inflammation in adults with knee osteoarthritis. The main question it aims to answer is:
\- Does the GAE procedure improve knee pain and decrease inflammation?
Researchers will compare synovial fluid samples taken from the knee before and after the procedure.
Participants will:
…
The goal of this clinical trial is to learn if genicular artery embolization (GAE) can improve knee pain and decrease inflammation in adults with knee osteoarthritis. The main question it aims to answer is:
\- Does the GAE procedure improve knee pain and decrease inflammation?
Researchers will compare synovial fluid samples taken from the knee before and after the procedure.
Participants will:
* Have a contrast enhanced MRI before and after the procedure
* Complete performance-based measures before and after the procedure
* Complete questionnaires before and after the procedure
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years
* Planned to undergo genicular artery embolization to treat knee osteoarthritis.
* Osteoarthritis on knee radiograph (Kellgren-Lawrence score 1-3) within the last 6 months
* Persistent moderate to severe knee pain (visual analog scale \[VAS\] \>3) for at least 6…
Inclusion Criteria:
* Age ≥ 18 years
* Planned to undergo genicular artery embolization to treat knee osteoarthritis.
* Osteoarthritis on knee radiograph (Kellgren-Lawrence score 1-3) within the last 6 months
* Persistent moderate to severe knee pain (visual analog scale \[VAS\] \>3) for at least 6 months
* Pain refractory or intolerant to conservative therapies (e.g. analgesia, exercise, weight-loss, joint injections, physical therapy)
* BMI \< 35 kg / m2
* Stated willingness to comply with study procedures and availability for the duration of the study
Exclusion Criteria:
* Coagulation disturbances not normalized by medical treatment (INR \>1.8 and platelets \<50 x 10\^9/L)
* Receiving medications for anticoagulation which cannot safely be held for the procedure (e.g ASA for 5 days, Lovenox for 24 hours, Eliquis for 4-6 days depending on creatinine clearance
* Allergy to iodinated contrast agents not responsive to steroid premedication regimen
* Active knee joint infection
* Acute knee injury with surgical indication (MRI evidence of acute fracture or ligamentous injury of the knee)
* Prior total or partial knee replacement in the subject knee
* Intra-articular steroid injection within 2 months
* Untreated lower extremity vascular arterial disease
* Untreated venous insufficiency
* Presence of medical condition with life expectancy less than 6 months
* Patients who have undergone previous lower extremity embolization
* Patients with renal insufficiency based on an estimated GFR\<45 ml/min who are not already on hemodialysis
* Patients who are pregnant or intend to become pregnant within 6 months of the procedure
* American Society of Anesthesiologists classification \> 3
* Less than 3 mm of synovial fluid in the lateral suprapatellar recess on MRI or US
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