Effectiveness of a New Service Delivery Model for Management of Knee Osteoarthritis in Primary Care: A Cluster Randomized Controlled Trial.

OBJECTIVE: To evaluate the effectiveness and health costs of a new primary care service delivery model (the Optimising Primary Care Management of Knee Osteoarthritis [PARTNER] model) to improve health outcomes for patients with knee osteoarthritis (OA) compared to usual care. METHODS: This study was a 2-arm, cluster, superiority, randomized controlled trial with randomization at the general practice level, undertaken in Victoria and New South Wales, Australia. We aimed to recruit 44 practices and 572 patients age ≥45 years with knee pain for >3 months. Professional development opportunities on best practice OA care were provided to intervention group general practitioners (GPs). All recruited patients had an initial GP visit to confirm knee OA diagnosis. Control patients continued usual GP care, and intervention patients were referred to a centralized care support team (CST) for 12-months. Via telehealth, the CST provided OA education and an agreed OA action plan focused on muscle strengthening, physical activity, and weight management. Primary outcomes were patient self-reported change in knee pain (Numerical Rating Scale [range 0-10; higher score = worse]) and physical function (Knee Injury and Osteoarthritis Outcome Score activities of daily living subscale [range 0-100; higher score = better] at 12 months. Health care cost outcomes included costs of medical visits and prescription medications over the 12-month period. RESULTS: Recruitment targets were not reached. A total of 38 practices and 217 patients were recruited. The intervention improved pain by 0.8 of 10 points (95% confidence interval [95% CI] 0.2, 1.4) and function by 6.5 of 100 points (95% CI 2.3, 10.7), more than usual care at 12 months. Total costs of medical visits and prescriptions were $3,940 (Australian) for the intervention group versus $4,161 for usual care. This difference was not statistically significant. CONCLUSION: The PARTNER model improved knee pain and function more than usual GP care. The magnitude of improvement is unlikely to be clinically meaningful for pain but is uncertain for function.

Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial).

INTRODUCTION: Knee osteoarthritis (KOA) is a highly prevalent disabling joint disease. Intra-articular stem cell therapy is increasingly being used for treating KOA with little high-quality evidence to support its use. The aim of this study is to investigate the efficacy, safety and cost-effectiveness of allogeneic mesenchymal stem cells (Cymerus MSCs) for treating symptomatic tibiofemoral KOA and improving knee structure over 24 months. METHODS AND ANALYSIS: The Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis study is a phase III, multi-centre, parallel, superiority, randomised, double-blind, placebo-controlled trial, which will be conducted in Sydney and Hobart, Australia. 440 participants (220 per arm) aged over 40 years with painful KOA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) with medial minimum joint space width between 1 and 4 mm in the study knee will be recruited from the community and randomly allocated to receive either intra-articular MSCs or saline at baseline, week 3 and week 52. The coprimary outcomes will be the proportion of participants achieving patient-acceptable symptom state for knee pain at 24 months and quantitative central medial femorotibial compartment cartilage thickness change from baseline to 24 months. Main secondary outcomes include change in knee pain, Patient Global Assessment, physical function, quality of life and other structural changes. Additional data for cost-effectiveness analysis will also be recorded. Adverse events will be monitored throughout the study. The primary analysis will be conducted using modified intention-to-treat. ETHICS AND DISSEMINATION: This protocol has been approved by The University of Sydney (USYD) Human Research Ethics Committee (HREC) #: 2020/119 and The University of Tasmania (UTAS) HREC #: H0021868. All participants will be required to provide informed consent. Dissemination will occur through conferences, social media, and scientific publications. TRIAL REGISTRATION NUMBERS: Australian New Zealand Clinical Trials Registry (ACTRN12620000870954); U1111-1234-4897.