Clinical trial for Knee Osteoarthritis
Official title Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06940479
What this study is testing
- What it's testing
- This study is testing whether a procedure called genicular artery embolization (GAE) helps. It looks at knee pain and swelling before and after the treatment.
- Who it's for
- You may be able to join if you are an adult with knee osteoarthritis.
- What's involved
- You would have the GAE procedure. You would also get two MRIs and fill out questionnaires.
- Time commitment
- The study involves visits for the procedure and tests before and after.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.