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In patients with knee osteoarthritis, pharmacological and non-pharmacological options are often not optimised prior to joint replacement. This results in some patients undergoing surgery when they are not as fit as they could be. The aim of this study is to assess the feasibility and acceptability of a pre-operative package of non-operative care versus standard care prior to joint replacement.<\/jats:p>\n<\/jats:sec>\nMethods\/design<\/jats:title>\nThis is a multicentre, randomised controlled feasibility trial of patients undergoing primary total knee replacement for osteoarthritis. Sixty patients will be recruited and randomised (2:1) to intervention or standard care arms. Data will be collected at baseline (before the start of the intervention), around the end of the intervention period and a minimum of 90\u2009days after the planned date of surgery. Adherence will be reviewed each week during the intervention period (by telephone or in person). Participants will be randomised to a pre-operative package of non-operative care or standard care. The non-operative care will consist of (1) a weight-loss programme, (2) a set of exercises, (3) provision of advice on analgesia use and (4) provision of insoles. The intervention will be started as soon as possible after patients have been added to the waiting list for joint replacement surgery to take advantage of the incentive for behavioural change that this will create. The primary outcomes of this study are feasibility outcomes which will indicate whether the intervention and study protocol is feasible and acceptable and whether a full-scale effectiveness trial is warranted.<\/jats:p>\nThe following will be measured and used to inform study feasibility: rate of recruitment, rate of retention at 90-day follow-up review after planned surgery date, and adherence to the intervention estimated through review questionnaires and weight change (for those receiving the weight-loss aspect of intervention). In addition the following information will be assessed qualitatively: analysis of qualitative interviews exploring acceptability, feasibility, adherence and possible barriers to implementing the intervention, and acceptability of the different outcome measures.<\/jats:p>\n<\/jats:sec>\nDiscussion<\/jats:title>\nThe aims of the study specifically relate to testing the feasibility and acceptability of the proposed effectiveness trial intervention and the feasibility of the trial methods.<\/jats:p>\nThis study forms the important first step in developing and assessing whether the intervention has the potential to be assessed in a future fully powered effectiveness trial. The findings will also be used to refine the design of the effectiveness trial.<\/jats:p>\n<\/jats:sec>\nTrial registration<\/jats:title>\nISRCTN registry, ID: ISRCTN96684272<\/jats:ext-link>. Registered on 18 April 2018.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s13063-019-3709-5","type":"journal-article","created":{"date-parts":[[2020,2,19]],"date-time":"2020-02-19T15:02:54Z","timestamp":1582124574000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY); a feasibility study protocol for a randomised controlled trial"],"prefix":"10.1186","volume":"21","author":[{"given":"A. Hamish R. 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Howie and Nicholas D. Clement.","order":6,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A favourable opinion was received from the South East Scotland Research Ethics Committee (REC) 2 on 18 January 2018 (REC ref.: \/SS\/0156). The study procedures will follow the protocol approved by the Ethics Committee and only patients who provide informed consent as per the study protocol will be included in this study.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Cambridge Weight Plan, Northants, UK provided weight loss products free of charge for the study. Counterweight provided training and support on the Counterweight-Plus programme. The other authors declare that they have no competing interests. PGC and SRK are supported by the National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (BRC).The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. ARL was medical director of Cambridge Weight Plan until 31st<\/sup> March 2019 but held no shares or options and holds no residual interests after retirement. ARL chairs the European industry group TDMR Europe.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"209"}}