Prospective registry for geniculate arterial embolisation as treatment for osteoarthritis and neovascularity. - Trial ANZCTR12622000621718

Timeline & Enrollment

Primary Outcome

Safety of the genicular artery embolisation (GAE) procedure measured by occurrence of adverse events as reported by the patient and investigators. Whilst severe or long-term complications are very rare, the most consistently reported side effect of GAE is non-target embolisation to the overlying skin resulting in temporary skin discoloration over the embolised territory. Other reported adverse events include moderate subcutaneous hemorrhage at the puncture site, small self-limiting groin hematoma, transient mild knee pain, self-resolving focal skin ulceration, and asymptomatic small bone infarct. ;; Overall efficacy of the genicular artery embolisation (GAE) procedure. This is a composite outcome. It is determined based on the results obtained from the changes in overall and current health status; patient-reported outcomes (PROMs); average knee joint pain; patient satisfaction and problems following GAE procedure; and patient expectations for pain, mobility, and health. These data will be collected from the study questionnaire.

Summary

Genicular artery embolisation (GAE) or embolisation of the knee is a minimally-invasive procedure used to reduce pain caused by KOA. GAE is a legitimate course of treatment for patients referred by their orthopaedic surgeons who meet the inclusion criteria. A small number of human studies investigating GAE in patients with knee osteoarthritis (KOA) have been conducted in Australia and internationally. We seek to establish a prospective registry on GAE to consolidate local experiences and collect evidence to affirm the safety and efficacy of GAE procedure in patients experiencing moderate-to-severe persistent chronic pain following total knee arthroplasty (TKA) and also those with moderate-to-severe knee OA who are not yet suitable for surgical intervention.

ICD-10 Classifications