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Background: The number of knee arthroplasties performed each year is steadily increasing. Although the outcome is generally favourable, up to 15 % fail to achieve a satisfactory clinical outcome which may indicate that the existing model of rehabilitation after surgery may not be the most efficacious. Given the increasing number of knee arthroplasties, the relative limited physiotherapy resources available and the increasing age and frailty of patients receiving arthroplasty surgery, it is important that we concentrate our rehabilitation resources on those patients who most need help to achieve a good outcome. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of a community-based multidisciplinary rehabilitation intervention in comparison to usual care., Methods/design: The trial is designed as a prospective, single-blind, two-arm randomised controlled trial (RCT). A bespoke algorithm to predict which patients are at risk of poor outcome will be developed to screen patients for inclusion into a RCT using existing datasets. Six hundred and twenty patients undergoing knee arthroplasty, and assessed as being at risk of poor outcome using this algorithm, will be recruited and randomly allocated to one of two rehabilitation strategies: usual care or an individually tailored community-based rehabilitation package. The primary outcome is the Late Life Function and Disability Instrument measured at 1 year after surgery. Secondary outcomes include the Oxford Knee Score, the Knee injury and Osteoarthritis Outcome Score quality of life subscale, the Physical Activity Scale for the Elderly, the EQ-5D-5L and physical function measured by three performance-based tests: figure of eight, sit to stand and single-leg stand. A nested qualitative study will explore patient experience and perceptions and a health economic analysis will assess whether a home-based multidisciplinary individually tailored rehabilitation package represents good value for money when compared to usual care., Discussion: There is lack of consensus about what constitutes the optimum package of rehabilitation after knee arthroplasty surgery. There is also a need to tailor rehabilitation to the needs of those predicted to do least well by focussing on interventions that target the elderly and frailer population receiving arthroplasty surgery., Trial Registration: ISRCTN 13517704 , registered on 12 February 2015.

Background: Colorectal cancer (CRC) is the second most common malignancy in Europe and a leading cause of cancer-related death. Almost 50% of patients with CRC develop liver metastases, which heralds a poor prognosis unless metastases can be downsized to surgical resection or ablation. The FOXFIRE trial examines the hypothesis that combining radiosensitising chemotherapy (OxMdG: oxaliplatin, 5-fluorouracil and folic acid) with Selective Internal Radiation Therapy (SIRT or radioembolisation) using yttrium-90 resin microspheres (SIR-Spheres®; Sirtex Medical Limited, North Sydney, Australia) as a first-line treatment for liver-dominant metastatic CRC will improve clinical outcomes when compared to OxMdG chemotherapy alone., Methods/design: FOXFIRE is an open-label, multicentre, randomised controlled trial of OxMdG with or without the addition of SIRT (1:1 randomisation). Eligible adult patients have histologically confirmed colorectal adenocarcinoma, liver metastases measurable on computed tomography scan and untreatable by either surgical resection or local ablation, and they may have limited extra-hepatic disease, defined as ≤5 nodules in the lung and/or one other metastatic site which is amenable to future definitive treatment. Eligible patients may have received adjuvant chemotherapy following resection of the primary tumour, but are not permitted to have previously received chemotherapy for metastatic disease, and must have a life expectancy of ≥3 months and a WHO performance status of 0-1. The primary outcome is overall survival. Secondary outcomes include progression free survival (PFS), liver-specific PFS, patient-reported outcomes, safety, response rate, resection rate and cost-effectiveness. FOXFIRE shares a combined statistical analysis plan with an international sister trial called SIRFLOX., Discussion: This trial is establishing a network of SIRT centres and 'feeder' chemotherapy-only centres to standardise the delivery of SIRT across the whole of the UK and to provide greater equity of access to this highly specialised liver-directed therapy. The FOXFIRE trial will establish the potential role of adding SIRT to first-line chemotherapy for unresectable liver metastatic colorectal cancer, and the impact on current treatment paradigms for metastatic CRC., Trial Registration: ISRCTN83867919.