None listed
Conditions
Brief summary
This sub-study is part of the PRAETORIAN registry (ACTRN12622000621718). The PRAETORIAN registry collects information on patients receiving genicular artery embolisation (GAE) to treat pain from knee osteoarthritis. In this sub-study, we will ask participants to provide blood samples at the same time points they complete questionnaires for the PRAETORIAN registry. These samples will be analysed at Queensland University of Technology to study biomarkers, which are indicators of biological processes in the body. By correlating biomarkers with questionnaire responses from the PRAETORIAN registry, we aim to understand how GAE affects the biological mechanisms of osteoarthritis and assess its treatment efficacy.
Interventions
This study is a sub-study of a clinical registry called the PRAETORIAN registry (ACTRN12622000621718). It aims to explore the correlation between a series of established biomarkers associated with osteoarthritis (OA) and the data collected as part of the PRAETORIAN registry. The PRAETORIAN registry is designed to collect data on the Genicular Artery Embolisation (GAE) procedure and patient outcomes to assess the safety and efficacy of GAE. Participants deemed suitable for recruitment into the PRAETORIAN registry will be invited to decide if they would also like to participate in the sub-study. The inclusion and exclusion criteria for the PRAETORIAN registry are as follows: Inclusion criteria for group A (patients with moderate-to-severe chronic pain following Total Knee Arthroplasty (TKA)): - Age 40 yrs or older who are willing and able to provide informed consent - Experiencing ongoing moderate to severe pain for at least 6 months after total knee arthroplasty - and having failed conservative medical treatment for at least 6 months (e.g. physiotherapy/anti-inflammatory/analgesia/masso-kinesiotherapy, etc.) Inclusion criteria for group B (patients with mild-to-severe Knee Osteoarthritis (KOA)): - Age 40 yrs or older who are willing and able to provide informed consent - Presence of mild to severe knee OA as stipulated by referring orthopedic surgeon - Presence of knee pain for at least 6 months, resistant to conservative treatments (e.g. physiotherapy, analgesia, exercise, weight loss, intra-articular injections, etc.) - Non-surgical candidates: ineligible/refused total knee arthroplasty (TKA) The data from these two groups are primarily intended to be collected in parallel. However, if notable findings emerge, the outcomes may be compared between the groups in the final analysis. Participants recruited for this sub-study will be asked to provide blood samples specifically for the purpose of this research at four time points: before their GAE procedure (baseline), and at 1, 6, and 12 months post-GAE procedure. The collected blood samples will be transferred to the Queensland University of Technology (QUT) for analysis, where they will be used to measure a panel of established biomarkers associated with osteoarthritis. The biomarker levels will be correlated with patient-reported outcomes recorded in the PRAETORIAN registry. These biomarkers are crucial for understanding the underlying biological processes of osteoarthritis and may reveal important insights into disease progression and treatment efficacy. This additional research seeks to enhance our understanding of the biological mechanisms that drive the patient-reported outcomes observed in the PRAETORIAN registry.
Sponsors
Eligibility
Inclusion criteria
Participants deemed suitable for recruitment into the PRAETORIAN registry will be invited to decide if they would also like to participate in the sub-study. The inclusion and exclusion criteria for the PRAETORIAN registry are as follows, and there are no additional criteria for inclusion in this sub-study beyond those listed for the PRAETORIAN registry. Inclusion criteria for group A (patients with moderate-to-severe chronic pain following Total Knee Arthroplasty (TKA)): - Age 40 yrs or older who are willing and able to provide informed consent - Experiencing ongoing moderate to severe pain for at least 6 months after total knee arthroplasty - and having failed conservative medical treatment for at least 6 months (e.g. physiotherapy/anti-inflammatory/analgesia/masso-kinesiotherapy, etc.) Inclusion criteria for group B (patients with mild-to-severe Knee Osteoarthritis (KOA)): - Age 40 yrs or older who are willing and able to provide informed consent - Presence of mild to severe knee OA as stipulated by referring orthopedic surgeon - Presence of knee pain for at least 6 months, resistant to conservative treatments (e.g. physiotherapy, analgesia, exercise, weight loss, intra-articular injections, etc.) - Non-surgical candidates: ineligible/refused total knee arthroplasty (TKA)
Exclusion criteria
The exclusion criteria are the same as those for the PRAETORIAN registry, with no additional exclusion criteria for this sub-study. The exclusion criteria are as follows: Exclusion criteria for group A (patients with moderate-to-severe chronic pain following Total Knee Arthroplasty (TKA)): - Rheumatoid, infectious arthritis, osteonecrosis, or advanced atherosclerosis - Malignancy - Renal impairment (eGFR <45) - A bleeding diathesis - Irreversible coagulopathy - Re-operation - Allergic to contrast media Exclusion criteria for group B (patients with mild-to-severe Knee Osteoarthritis (KOA)): - Rheumatoid, infectious arthritis, osteonecrosis, or advanced atherosclerosis - Malignancy - Renal impairment (eGFR <45) - A bleeding diathesis - Irreversible coagulopathy - Allergic to contrast media