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. Prior to a full randomised trial, 10 participants will be recruited to this non-randomised pilot study. The purpose of the pilot study is to test the protocol for feasibility and assess for effects on pain and function and any unexpected effects due to the intervention in the first month post procedure. All pilot study participants will unblinded and will receive the intervention. Participants will be reassessed the day following the intervention and then once a week for the first month. At each assessment, participants will complete an abbreviated assessment (KOOS, Global Assessment of Change, Six Minute Walk Test and 30-second Chair Stand Test). Participants will then complete full assessments (using all assessment tools) at 1, 6, 12, and 24 months following the procedure.
Interventions
Participants will have abnormal blood vessels about the study knee embolised. Participants will receive a local anaesthetic (1% lignocaine) injected into their groin. Femoral artery access will be obtained with a 3French sheath and a micro-catheter introduced. Digital subtraction angiogram 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 <50
Participants will have abnormal blood vessels about the study knee embolised. Participants will receive a local anaesthetic (1% lignocaine) injected into their groin. Femoral artery access will be obtained with a 3French sheath and a micro-catheter introduced. Digital subtraction angiogram 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 <500um embolic material. 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
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. People aged 18 to 75 years 2. Grade 1 or 2 knee OA (obtained via baseline imaging (X-Ray) as per Kellgren-Lawrence Grading Scale) 3. Moderate to severe knee pain 4. 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. 5. 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. Reduced kidney function or failure (chronic or acute) a. Acute kidney injury (Defined by KDIGO: Increase in a participant’s serum creatinine level by >0.3mg/dL (>26.5 micromol/L) within 48 hours OR Increase in a participants serum creatinine by >1.5x their baseline OR Oliguria (urinary output <0.5mL/kg/hr) for 6 hours 9. Weight greater than 200kg 10. Barwon Medical Imaging Protocols: a.Platelets < 100 x 109/L b. INR > 1.5 c. Estimated GFR < 30ml/min.1.73m2 11. Approved for knee joint replacement surgery 12. Moderate to severe pain in other lower limb joints
Outcome results
None listed