Genicular artery embolisation and the effect on Knee Osteoarthritis - a randomised controlled trial. - Trial ANZCTR12622001157763

Timeline & Enrollment

Primary Outcome

Safety of transcatheter arterial embolisation of genicular arteries in the treatment of pain from knee osteoarthritis. Safety will be monitored at a variety of check points. all adverse events will documented and alerted to the principle sponsor and the local HREC office. ;; Efficacy of transcatheter arterial embolisation of genicular arteries in the treatment of pain from knee osteoarthritis. Treatment efficacy is assessed via a composite of the VAS and Knee injury and osteoarthritis outcome score. ;; Assessment of pain in patients who undergo genicular artery embolisation in comparison with the control group who do not undergo the procedure. Pain will be assessed by a composite of the Visual analogue scale, Knee injury osteoarthritis outcome score and the usage of their analgesia (reduction or increase). Analgesia usage will be determined by review of the participants diaries.

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.

ICD-10 Classifications