Embolization treatment for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.