None listed
Conditions
Brief summary
Osteoarthritis (OA) is a chronic and progressive condition affecting 1 in 8 Australians. Recent advancement suggests that there is a vascular (formation of new vessels) and inflammatory component associated with OA. Osteoarthritis of the knee is the most common form of OA. The risk of functional limitations from knee osteoarthritis is greater than that from any other medical condition for those aged 65 and above. Blockage (embolisation) of these newly developed blood vessels in knee OA represents a method to reduce a patient's symptoms but also delay the progression of their condition. Across Japan, USA and UK, many researchers have looked at the safety and efficacy in carrying out embolisation of geniculate arteries. These studies have shown a reduction in patient’s pain and nil adverse outcomes associated with the procedure itself. This procedure represents a potential intermediate management tool with reduction in the costs associated with total knee replacements as well as increasing economic productivity for patients and the community. This study hypothesises that patients who undergo blockage of the newly developed vessels will result in a reduction in analgesic consumption and an increase in quality of life for patients in comparison to the placebo. This study aims to compare geniculate artery embolisation with non-procedural intervention to ascertain further data and aid the growing literature in the global community for the use of this procedure as a method to manage patients with osteoarthritis. Participants will be assessed prior with a thorough clinical/medication history, physical examination and a questionnaire (visual analogue scale and Knee injury and osteoarthritis severity score) related to the patient’s experience with regards to their knee issues. Once the participant has consented and enrolled in the study. The study will randomise participants into an intervention group (those that receive the blockage of vessels) and those that do not. Both participants will be followed up post procedure at the 1 day, 1 week, 1 month, 3-month, 6 month and 12-month mark for functional and subjective assessment of the knee.
Interventions
The research team will be studying the impact that embolisation of neo-vascularisation of the geniculate arteries has on patient’s pain and functional outcomes associated with their knee osteoarthritis.
Brief name: geniculate artery embolization, there will be two arms to this study; an intervention arm and a placebo/control arm.
The procedures will be carried out face to face by a qualified Interventional Radiologist with a minimum of 3 years’ experience of performing endovascular procedure
The research team will be studying the impact that embolisation of neo-vascularisation of the geniculate arteries has on patient’s pain and functional outcomes associated with their knee osteoarthritis. Brief name: geniculate artery embolization, there will be two arms to this study; an intervention arm and a placebo/control arm. The procedures will be carried out face to face by a qualified Interventional Radiologist with a minimum of 3 years’ experience of performing endovascular procedures. The procedures will be carried out at the interventional radiology department within Liverpool Hospital, NSW, Australia. The team aims to carry out one procedure for each participant with the timing of procedures ranging from 2-3hours. Intervention description: The contralateral/ipsilateral femoral artery or ipsilateral dorsalis pedis artery will be assessed with ultrasound. The region will be prepped utilising sterile technique. The artery will be punctured; an endovascular sheath used to replace the needle using seldinger technique. Guide wires, angiographic catheters/microcatheters will be advanced to the affected knee and the abnormal/neovascularised vessels will be imaged with diagnostic angiography. The abnormal arteries will then be embolised utilising micron embosphere beads. Vessel anatomy and the abnormal/neovascularised vessels will differ from one patient to another. Thus, each participant will have personalised or adapted treatment. These personalised differences will range from - Puncture/ arterial access site. - Type of catheters/microcatheters used. - Number of vessels embolised. - Determine the number of vessels needed to be embolised due to the patient’s symptoms at the time of the original consultation. These treatment differences will occur at the time of the intervention. The procedure is a one time procedure, there is no need for strategies to monitor adherence/fidelity.
Sponsors
South Western Sydney Local health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
41 Years to No maximum
Healthy volunteers
No
Inclusion criteria
>40 years of age. Grade 2 and 3 knee Osteoarthritis on plain radiographs (Kellgren-lawrence scale). Knee pain for 6 months or more, moderate to severe knee pain (VAS >50mm). Pain refractory to conservative management for at least 3 months. Patients capable of consenting for the trial.
Exclusion criteria
Current local infection. Life expectancy is less than 6 months. Active malignancy. Grade 1 or 4 knee OA on x-rays as per Kellgren-Lawrence Grading scale. Known advanced atherosclerosis in lower limb. Rheumatoid or infectious arthritis. Prior ipsilateral knee surgery excluding arthroscopic surgery more than three months ago. Uncorrectable coagulopathy greater with INR greater than 1.5 (APTT will not be taken). Renal dysfunction as defined by eGFR <45 within the last 60 days. Contraindications for MR imaging. Known history of allergy to contrast media. Women who are lactating, pregnant or trying to become pregnant. Patients with a history of psychological illness, especially severe depression.
Outcome results
None listed