Knee Artery Embolization for Osteoarthritis
Recruiting in Palo Alto (17 mi)
Overseen ByAndre Uflacker, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
No Placebo Group
Trial Summary
What is the purpose of this trial?The objective of this study is to investigate if MRI can be used to evaluated effect of knee artery embolization for knee osteoarthritis. Participants be evaluated in clinic, obtain a knee MRI, undergo embolization of the symptomatic knee, and follow up in clinic at 1, 6, and 12 months after embolization. A second MRI is obtained 6 months after embolization. Participants will keep a record of their pain level and treatment and answer questionnaires at each visit.
In addition, this study aims to determine the effects of knee artery embolization on the amount of opioid (pain reliever drugs) needed to manage osteoarthritis-associated pain and change in quality of life.
How is the treatment geniculate artery embolization different from other treatments for knee osteoarthritis?
Geniculate artery embolization (GAE) is a unique treatment for knee osteoarthritis that involves blocking specific blood vessels in the knee to reduce pain and inflammation, unlike traditional treatments that often rely on medications or surgery. This minimally invasive procedure targets the blood supply to the inflamed areas, potentially offering relief for patients with refractory pain who do not respond well to other therapies.
13468What data supports the effectiveness of the treatment Knee Artery Embolization for Osteoarthritis?
Research suggests that genicular artery embolization (a procedure that blocks blood flow to certain knee arteries) may help reduce pain in people with knee osteoarthritis, especially when other treatments haven't worked. Some studies indicate it could be a promising option for managing symptoms.
12689Is knee artery embolization safe for treating osteoarthritis?
Research on genicular artery embolization (GAE) for knee osteoarthritis shows it is generally safe, with most patients experiencing only minor side effects like temporary knee stiffness or skin bruising. No major procedure-related adverse events were reported in the studies.
14578Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it does mention that participants should have been on non-surgical therapy like joint injections, oral NSAIDs, or opioid analgesia for at least one month before joining.
Eligibility Criteria
This trial is for adults aged 25-90 with knee osteoarthritis, who've tried non-surgical pain treatments like injections or NSAIDs. They must be able to consent and have no MRI contraindications, severe kidney issues, malignancy in the knee, rheumatoid arthritis/gout, recent septic arthritis, or past major knee surgery.Inclusion Criteria
I have knee pain due to arthritis, confirmed by an X-ray.
I can safely undergo MRI scans with contrast.
I can understand and agree to the study's terms on my own.
I am between 25 and 90 years old.
Exclusion Criteria
I have Rheumatoid Arthritis or Gout.
I have bleeding within my joints.
My knee cancer is confirmed.
I have had knee surgery before.
My kidney function is low, with a GFR under 30ml/min.
I am not pregnant nor planning to become pregnant during the study.
I have severe artery disease in my legs that prevents certain artery procedures.
Participant Groups
The study tests if geniculate artery embolization reduces pain from knee osteoarthritis and improves quality of life. It involves initial/follow-up clinic visits, two MRIs (one before and one six months after treatment), and participants tracking their pain levels.
1Treatment groups
Experimental Treatment
Group I: GAE and MRI treatment armExperimental Treatment2 Interventions
GAE is geniculate artery embolization.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
BayerIndustry Sponsor
References
Technically Successful Geniculate Artery Embolization Does Not Equate Clinical Success for Treatment of Recurrent Knee Hemarthrosis after Knee Surgery. [2016]To evaluate technical details, clinical outcomes, and complications in patients undergoing geniculate artery embolization for treatment of spontaneous hemarthrosis after knee surgery.
The Value of Preprocedural MR Imaging in Genicular Artery Embolization for Patients with Osteoarthritic Knee Pain. [2020]To determine the value of preprocedural MR imaging in genicular artery embolization (GAE) for patients with osteoarthritic knee pain.
Genicular Artery Embolization for Refractory Hemarthrosis following Total Knee Arthroplasty: Technique, Safety, Efficacy, and Patient-Reported Outcomes. [2021]To investigate the safety and efficacy of genicular artery embolization for treatment of refractory hemarthrosis following total knee arthroplasty.
Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. [2022]To assess the safety and efficacy of genicular artery embolization (GAE) compared with a sham procedure in the treatment of knee pain secondary to mild to moderate osteoarthritis (OA).
[Efficacy analysis of selective genicular artery embolization in the treatment of knee pain secondary to osteoarthritis]. [2022]Objective: To evaluate the efficacy and safety of selective genicular artery embolization for the treatment of the knee pain secondary to osteoarthritis. Methods: From October 2020 to July 2021, 17 patients (23 knees) aged (68±7) years with moderate to severe knee pain secondary to knee osteoarthritis were prospectively included in the General Hospital of Ningxia Medical University. There were 6 males and 11 females included in this research. Patients were assessed with knee pain, stiffness, and function with the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, using the Kellgren-Lawrence (K-L) grading to evaluate the severity of KOA, and using the Magnetic Resonance Knee Osteoarthritis Score (MOAKS) to evaluate the MR imaging characteristics of the affected knee. Selective genicular artery embolization (GAE) was performed in all patients. The patients were followed up for 6 months after the procedure. Patients were assessed with the VAS score and WOMAC scale at 1 d, 1 week and 1, 3 and 6 months after the procedure to evaluate the clinical outcomes, including the improvement of knee joint pain, stiffness and function, as well as the occurrence of adverse reactions. Results: Three to seven genicular artery branches were superselected and embolized in 23 knees, and 4 to 7 genicular artery branches were embolized in 7 patients with K-L grade 4. The clinical improvement was 95.6% (22/23) at 1 month, 86.9% (20/23) at 3 months, and 91.3% (21/23) at 6 months. Twenty-three knees completed the 6-month follow-up, and the VAS score, WOMAC pain score, and total WOMAC score at 1, 3, and 6 months after surgery were (2.5±1.3), (3.4±2.4), and (19.7±9.8) points, (3.0±1.8), (4.5±3.4), and (22.3±11.3) points, (2.8±1.5), (4.1±3.0), and (20.5±11.0) points, which were lower than the (6.6±0.9), (11.4±2.6) and (47.0±12.0) points at baseline (all P<0.001). During the follow-up period, 7 patients had adverse reactions: 3 cases had skin ecchymosis in the femoral artery puncture area, 4 cases had knee joint stiffness and pain within 1 day after operation, which were relieved spontaneously in 1 week, 6 patients had joint clicking during extension and flexion activities after operation, of which 3 cases subsided spontaneously within 3 months after operation. None of the patients had major procedure-related adverse events. Conclusion: GAE has a high clinical improvement rate and a low incidence of adverse reactions in the treatment of the pain secondary to knee osteoarthritis, which provides a new treatment option for patients who fail to respond to conservative treatment.
[Embolization of genicular arteries in patients with knee osteoarthritis as an alternative for refractory pain treatment: A systematic review]. [2022]Genicular artery embolization emerges as an innovative technique described for the treatment of refractory pain in patients with knee osteoarthritis. This review summarizes the available data on the efficacy of genicular artery embolization in patients with knee osteoarthritis (OA) and refractory pain as an alternative treatment or associated with pharmacological treatment.
Outcomes after Genicular Artery Embolization Vary According to the Radiographic Severity of Osteoarthritis: Results from a Prospective Single-Center Study. [2023]This prospective single-center study compared outcomes after genicular artery embolization (GAE) in people with mild radiographic knee osteoarthritis (OA) (n = 11) versus moderate to severe radiographic knee OA (n = 22). The mild OA group was older and had experienced symptoms for less time (P
Genicular Artery Embolization for Treatment of Knee Osteoarthritis: Interim Analysis of a Prospective Pilot Trial Including Effect on Serum Osteoarthritis-Associated Biomarkers. [2023]To characterize the safety, efficacy, and potential role of genicular artery embolization (GAE) as a disease-modifying treatment for symptomatic knee osteoarthritis (OA).
Common Design, Data Elements and Core Outcome Measures Reported on Clinical Trials of Genicular Artery Embolization for Knee Osteoarthritis: An Interactive Systematic Review. [2023]Genicular artery embolization (GAE) is an emerging, potentially effective treatment option in patients with knee osteoarthritis (OA). This study aimed to describe the current state of common design data elements (CDDEs) and core outcome measures (COMs) in recent trials of GAE for knee OA.