Genicular Artery Embolisation for Knee Osteoarthritis II
Key facts
- Who runs it
- Varian, a Siemens Healthineers Company
- Where
- United Kingdom1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 110 people, planned
- Started
- 30 Oct 2022
- Expected to end
- 30 Jun 2028
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Genicular Artery Embolisation
- Genicular Artery Injection
- Record updated
- 3 December 2024
Who can take part
- Age
- 45 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- Pregnancy or positive pregnancy test (the participant will be exposed to ionising radiation during the fluoroscopy procedure)
- 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
- 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
- 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
- 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)
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This clinical study is designed as a double-blind sham controlled randomised trial with the option of sham group crossover to receive the GAE treatment at 6 months after unblinding. This study will determine if embolisation of abnormal neovasculature arising from branches of the genicular arteries reduces pain in patients with knee osteoarthritis. The study patient population will consist of up to 110 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures. Subjects will be treated with knee embolisation or 2 mL of saline in the sham arm. At 6 months, all subjects in the sham arm will be allowed to cross-over and receive the embolisation procedure with a follow-up duration of 18 months. The total planned study duration is 3.5 years.
The 2 groups in the trial
- GAE TreatmentTreatment being tested
The genicular artery embolisation procedure identifies abnormal blood vessels in the knee via angiogram imaging. Through groin access and puncture of the femoral artery through a small sheath tiny microspheres (Embozene(TM)) will be injected into this area and reduce blood flow in order to reduce pain.
Treatment: Genicular Artery Embolisation
- Sham ProcedureSham treatment, for comparison
In the control (sham) arm patients will not undergo the embolisation procedure with microspheres, instead they will have 2ml of saline injected into their knee artery supplying the abnormal area of the knee. The remainder of the procedure is otherwise identical between the two groups.
Treatment: Genicular Artery Injection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Genicular artEry embolisatioN in patiEnts With oSteoarthrItiS of the Knee II
- Record updated
- 3 December 2024