None listed
Conditions
Brief summary
Knee osteoarthritis (OA) is a leading cause of pain and disability around the world. OA involves the breakdown of joint cartilage, but it also appears to include the proliferation of blood vessels and nerves about the joint. It is suggested that these blood vessels and nerves contribute to the experience of pain. One pilot study found that embolising abnormal vessels about the knee substantially improved individual's pain. The primary aim of the current study is to determine whether transcatheter arterial embolisation of abnormal neovasculature about the knee improves pain. Secondary aims include whether embolisation improves physical function, quality of life, joint stiffness, and medication usage. The study is a randomised controlled trial. People are eligible if they have knee OA that is not yet ready for knee replacement surgery and have tried other forms of traditional management such as medications and physiotherapy. Participants will be randomly allocated to one of two groups: intervention or placebo. Participants in the intervention group will receive embolisation of abnormal vessels about the knee. Participants in the control group will receive a placebo intervention that looks and feels like the real intervention but does not include embolisation of abnormal blood vessels. All participants will be assessed shortly before the intervention (real or placebo) and then 1, 6 and 12 months after the intervention. Participants in the intervention group will also be assessed 24 months following the intervention. Assessment includes a variety of questionnaires and physical tests.
Interventions
Participants in the treatment group will have abnormal blood vessels about the study knee embolised. Participants will receive a local anaesthetic injected (1% lignocaine) into their groin. Femoral artery access will be obtained with a 3French sheath and a micro-catheter introduced. Digital subtraction angiography using contrast (iodine-containing contrast medium) will be obtained of the knee identifying abnormal neovasculature arising from the genicular arterial branches. The abnormal vessels w
Participants in the treatment group will have abnormal blood vessels about the study knee embolised. Participants will receive a local anaesthetic injected (1% lignocaine) into their groin. Femoral artery access will be obtained with a 3French sheath and a micro-catheter introduced. Digital subtraction angiography using contrast (iodine-containing contrast medium) will be obtained of the knee identifying abnormal neovasculature arising from the genicular arterial branches. The abnormal vessels will be embolised with a suspension of 0.5 g of Imipenem and cilastatin sodium (IPM-CS)(Primaxin; Merck & Co. Inc., Whitehouse Station, NJ, USA) in 5mL of iodinated contrast agent (prepared by pumping syringes for 10 seconds) will be injected in 0.2mL increments until blood flow stagnates. The guide wire will be removed. A dressing will be applied to the puncture site. All procedures will be conducted by a fully qualified interventional radiologist who is trained to perform vascular embolisation. The procedure is expected to take 30-60minutes depending on the number of vessels embolised.
Sponsors
Barwon Medical Imaging
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. People aged 18 to 75 years 2. Grade 2 knee OA (obtained via baseline imaging (X-Ray) as per Kellgren-Lawrence Grading Scale) 3. Moderate to severe knee pain 4. Knee pain for at least six months 5. Pain resistant to conservative treatment a. Conservative treatment includes medication (e.g. paracetamol, anti-inflammatories), or intra-articular injections, or physiotherapy or exercise, or weight loss. 6. Participants must be willing, able and mentally competent to provide informed consent (able to read and understand the Patient Information and Consent Form)
Exclusion criteria
1. Local infection 2. Active malignancy 3. Rheumatoid Arthritis or Seronegative Arthropathies 4. Prior Ipsilateral Knee Surgery 5. Kellgren-Lawrence Grade 3 and above 6. Current pregnancy a. If participant is unsure of their current pregnancy status clarification from their GP including arranging a pregnancy test and following up the result can be obtained 7. Known history of allergy to contrast media 8. Weight greater than 200kg 9. Barwon Medical Imaging Protocols: a.Platelets < 100 x 109/L b. INR > 1.5 c. Estimated GFR < 30ml/min.1.73m2 10. Approved for knee joint replacement surgery 11. Moderate to severe pain in other lower limb joints 12. History of allergy to carbapenem (e.g. imipenem, ertapenem or meropenem), or having an immediate or severe hypersensitivity reaction to a penicillin or cephalosporin antibiotic 13. History of seizures or using valproate
Outcome results
None listed