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

Genicular artery embolisation (GAE) or embolisation of the knee is a minimally-invasive procedure used to reduce pain caused by knee osteoarthritis (KOA). We aim to establish a prospective registry to collect evidence on the safety and effectiveness of GAE in two distinct patient groups: a) patients experiencing moderate-to-severe persistent chronic pain due to neovascularization or haemarthrosis following total knee arthroplasty (TKA), and b) patients with mild-to-severe KOA refractory to conservative or medical therapies who are not currently suitable total knee arthroplasty (TKA) candidates. Patients referred by orthopaedic consultants (following the start date of the registry) to undergo GAE will be approached to be included in the registry. During the screening, the investigators will describe the nature of the patient registry and assess potential participants’ eligibility according to the registry’s inclusion/exclusion criteria. Eligible participants will be provided with a Patient Information and Consent Form (PICF). Participation in the prospective registry will be voluntary and potential participants will be given enough time to decide whether or not to take part in the registry. Referred patients will undergo the GAE procedure (per the investigational site’s standard of care) irrespective of their decision. Examinations, evaluations, treatment and hospital discharge procedures will be conducted per the investigational site’s standard of care. Registry subjects are to be followed according to the investigational sites’ standard of care practices. There are no additional treatments or scans to be performed for the purpose of this registry. The only difference between the routine clinical practice and this registry is that participants will be asked to complete an online questionnaire at baseline and at 1, 6 and 12 months (±2 weeks) post-GAE for the registry. The anticipated time needed to complete the online questionnaire at each time point is 25 minutes. The subject’s following information will be collected (directly from their health records and/or via a Data Collection form) for the registry: - Demographic information (e.g. date of birth, sex, BMI, etc.) - Medical history and list of medication - FBC and U&E blood test results - Knee radiographs and magnetic resonance imaging (MRI) results and interpretations. Imaging will be usually performed prior to GAE and may be repeated at the follow-up consultation at 3 months (±2 weeks) as per the investigational site’s standard of care - Procedural information (e.g. type of embolic used, length of the procedure, injected contrast volume, skin dose, amount of embolic used, etc.) - Adverse events (AEs) will be documented immediately after the GAE procedure and at the follow-up consultation at 3 months (±2 weeks) as per the investigational site’s standard of care. Each AE will be classified for its severity, or the intensity of an event, experienced by the subject The online questionnaire will consist of the validated and standardised questionnaires used by the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) for patients undergoing knee replacement procedures. These include: 1. EQ-5D-5L questionnaire. The EQ-5D-5L is a standardised instrument for measuring overall health status. The descriptive system is comprised of 5 dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression. 2. EQ VAS. The EQ VAS is a validated self-rated health instrument. Patients are asked to indicate their current health status on a scale from 0 (the worst health patient can imagine) to 100 (the best health patient can imagine). 3. Oxford Knee Score. The Oxford Knee Score (OKS) is a standardised and validated patient-reported outcomes (PROMs) instrument developed to assess function and pain in patients undergoing knee surgery. The OKS provides a single summed score; the lower the scoring, the higher the severity of the patient’s problems. 4. KOOS-12. The KOOS-12 instrument is a 12-item measure derived from the original Knee Injury and Osteoarthritis Outcome Score (KOOS). KOOS-12 contains 4 KOOS Pain items, 4 KOOS Function (Activities of Daily Living and Sport/Recreation) items, and 4 KOOS Quality of Life (QOL) items. KOOS-12 reduces respondent burden by 70% from the original KOOS while providing scale scores for knee-specific pain, function and QoL, along with a summary measure of overall knee impact. To interpret KOOS scoring, the outcome measure is a scale from worst to best from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. 5. Average pain scale (last 7 days). Patients will use a scale to indicate the average knee joint pain they had experienced over the last 7 days (from 0: no pain at all to 10: the worst pain imaginable). 6. Expectation questions. Patients will be asked their expectations for pain, mobility, and health in 1, 6 and 12 months’ time at the pre-operative collection point. At the post-GAE collection point, patients will rate their perceptions based on that day. 7. Satisfaction and joint change questions. At 1, 6 and 12 months post-GAE timepoints, patients will be asked to describe how satisfied they are with the results of their procedures and their perceived change in the problems associated with their knee. 8. Side effects/Complications question. At 1, 6 and 12 months post-GAE timepoints, patients will be asked to describe whether they experienced any side effects/complications following GAE. The use of these questionnaires will allow us to directly compare GAE results with those collected from patients undergoing total knee replacement procedures from the National Joint Registery. The direct comparison is expected to provide crucial information for orthopaedic surgeons and affect future KOA pain management plans.