None listed
Conditions
Brief summary
The iROAR registry is a prospective, multicentre observational study designed to evaluate the real-world effectiveness of low-dose radiotherapy (LDRT) in adults with symptomatic osteoarthritis across Australia. Participants receiving standard-of-care LDRT will be followed for up to 24 months to assess changes in pain, physical function, and health-related quality of life using validated patient-reported outcome measures. The primary objective is to determine the proportion of treated joints achieving a clinically meaningful response at 6 months based on OMERACT-OARSI criteria. Secondary outcomes include long-term clinical response, safety, retreatment rates, and healthcare utilisation outcomes associated with LDRT. The registry aims to generate the first prospective Australian dataset to inform clinical practice, treatment standardisation, and future research on LDRT for osteoarthritis.
Interventions
Participants enrolled in the registry will receive low-dose radiotherapy (LDRT) as part of standard clinical care for the management of symptomatic osteoarthritis. LDRT is delivered to the affected joint using either photon or electron radiotherapy techniques, as determined by the treating Radiation Oncologist.
The recommended dosing regimen consists of a total dose of 3 Gy administered in 6 fractions (0.5 Gy per fraction) over approximately 2–3 weeks, typically delivered on alternate days.
Trea
Participants enrolled in the registry will receive low-dose radiotherapy (LDRT) as part of standard clinical care for the management of symptomatic osteoarthritis. LDRT is delivered to the affected joint using either photon or electron radiotherapy techniques, as determined by the treating Radiation Oncologist. The recommended dosing regimen consists of a total dose of 3 Gy administered in 6 fractions (0.5 Gy per fraction) over approximately 2–3 weeks, typically delivered on alternate days. Treatment is planned and delivered according to institutional radiotherapy protocols, with the treatment field encompassing the painful joint and adjacent periarticular structures. Participants may receive one additional course of LDRT (retreatment) to the same joint at the discretion of the treating clinician, no earlier than 12 weeks after completion of the initial course, with a maximum cumulative dose of 6 Gy to the treated joint. This registry is observational, and no experimental intervention is administered. The exposure of interest is the receipt of LDRT for osteoarthritis within routine clinical practice.
Sponsors
Integrated Clinical Oncology Network (ICON) Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria Adults aged 18 years and over. Participants with a pre-existing diagnosis of osteoarthritis (OA). Participants presenting to a participating centre to receive low-dose radiotherapy (LDRT) for symptomatic OA and deemed suitable for treatment by the treating Radiation Oncologist. Evidence of OA affecting at least one joint (e.g., shoulder, hip, hand, wrist, elbow, knee, ankle, or foot), consistent with standard clinical assessment. Able and willing to provide written informed consent to participate in the registry.
Exclusion criteria
Key Exclusion Criteria Participants not eligible to receive low-dose radiotherapy (LDRT) for osteoarthritis, as determined by the treating Radiation Oncologist. Severe osteoarthritis (Kellgren–Lawrence grade 4). Previous radiotherapy to the affected joint. Planned or scheduled joint surgery for the affected joint within the study follow-up period (2 years). History of prior surgery on the affected joint. Current participation in another clinical trial for treatment of osteoarthritis. Autoimmune conditions affecting the joint (e.g., rheumatoid arthritis, lupus). Fibromyalgia diagnosis.
Outcome results
None listed