Embolization treatment for knee osteoarthritis
Genicular artEry embolisatioN in patiEnts With oSteoarthrItiS of the Knee II
This study is testing if a new procedure called genicular artery embolization can help people with knee osteoarthritis pain when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Varian, a Siemens Healthineers Company Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Reading) |
| Trial ID | NCT05423587 on ClinicalTrials.gov |
What this trial studies
This clinical study is a double-blind, sham-controlled randomized trial aimed at evaluating the effectiveness of genicular artery embolization (GAE) in reducing pain for patients suffering from knee osteoarthritis. Up to 110 participants with knee pain resistant to conservative treatments will be enrolled and randomly assigned to receive either the GAE procedure or a saline injection as a sham treatment. After 6 months, those in the sham group will have the option to crossover and receive the GAE treatment, with follow-up assessments extending for 18 months. The study will also include various assessments such as MRI and psychological evaluations to identify predictors of treatment success.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 and older with grade 1-3 knee osteoarthritis and persistent knee pain for at least 3 months despite conservative treatments.
Not a fit: Patients with severe knee osteoarthritis (grade 4), rheumatoid arthritis, or renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce knee pain and improve quality of life for patients with knee osteoarthritis.
How similar studies have performed: While the approach of genicular artery embolization is relatively novel, similar studies have shown promising results in treating knee osteoarthritis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ALL inclusion criteria below need to be fulfilled for the patient to participate in the study. * Participant is willing and able to give informed consent for participation in the study. * Participants aged 45 years or above. * Grade 1-3 knee OA on X-ray as per Kellgren-Lawrence Grading Scale * Knee pain for at least 3 months resistant to conservative non-surgical treatment (e.g., physiotherapy, steroid injections, weight loss programs, PRP (platelet-rich plasma) injections) * Be able to lie flat for at least 6 hours-this will be assessed by asking how participants sleep (bed, chair recumbent, semi-recumbent) and assessing what prevents them from lying flat overnight (breathlessness, back pain, etc) * Minimum score of 50 on baseline 0 - 100 VAS Exclusion Criteria: The patient may not enter the study if ANY of the following apply: * Rheumatoid arthritis or infectious arthritis * Severe knee OA (grade 4 on x-ray as per Kellgren-Lawrence Grade) * Renal impairment: eGFR \<45. Assessed from medical records or a blood test if required as is part of standard clinical practice when considering a patient for a therapeutic intervention. * Patients with a bleeding diathesis, or other bleeding risk such as patients on warfarin which cannot be stopped easily (e.g., patients with metallic heart valves) assessed by asking the patient and from medical records. Uncorrectable bleeding diathesis: INR\>1.6, Platelets \<50,000 * Requires oxygen on ambulation. Assessed by asking the patient and from medical records. * Low life expectancy (\<1 year) * Communication difficulty due to language barriers * Contraindication to MRI * Known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene or IV radiopaque contrast agent * History of Peripheral Arterial Disease (PAD) with intermittent claudication and/or rest pain * Pregnancy or positive pregnancy test (the participant will be exposed to ionising radiation during the fluoroscopy procedure) * Any other significant disease or disorder which, in the opinion of the recruiting physician, may put the participants at risk because of participation in the study, or may influence the result of the study or the participant's ability to participate
Where this trial is running
Reading
- Royal Berkshire NHS Foundation Trust — Reading, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Mark W Little, MD — Royal Berkshire NHS Foundation Trust, Reading, UK
- Study coordinator: Heike S Hausen, MD
- Email: Heike.Hausen@varian.com
- Phone: 2068903102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.