Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis
NCT ID: NCT06940479
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
46 participants
INTERVENTIONAL
2025-07-16
2028-07-31
Brief Summary
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\- 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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GAE procedure
Participants undergoing the GAE procedure will have synovial fluid sampling, performance-based measures and contrast-enhanced MRI before and after the procedure.
GAE procedure
Genicular artery embolization
Interventions
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GAE procedure
Genicular artery embolization
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Leigh Casadaban, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Shireen Shikak, BS
Role: primary
Other Identifiers
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24-1048
Identifier Type: -
Identifier Source: org_study_id
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