Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GAE procedure.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Genicular Artery Embolization for Knee Osteoarthritis: Evaluation of the Correlation Between Subjective Symptom Response and Objective Measures of Inflammation
Overview
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
Interventions
- Procedure GAE procedure
Genicular artery embolization
Primary outcome measures
- Measure changes in KOOS score and synovial fluid biomarkers [Time frame: 3 months after GAE procedure]
Secondary outcome measures (6)
- Measure changes in synovial enhancement with contrast-enhanced MRI according to WORMS synovitis scores [Time frame: 3 months after GAE procedure]
- Measure changes in synovial enhancement with contrast-enhanced MRI according to MOST grading system [Time frame: 3 months after GAE procedure]
- Measure changes in VAS scores [Time frame: 12 months after procedure]
- Measure changes in KOOS scores [Time frame: 12 months after procedure]
- Estimate correlation between objective measures to symptomatic response [Time frame: 3 months after GAE procedure]
- Estimate correlation between changes in a larger set of synovial fluid biomarkers and changes in subjective scores [Time frame: 3 months after GAE procedure]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Colorado Anschutz Medical Campus — Aurora
Identifiers
NCT: NCT06940479 · 24-1048