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

Simpson, A. Hamish R. W.; Howie, Colin R.; Kinsella, Elaine; Hamilton, David F.; Conaghan, Philip G.; Hankey, Catherine; Simpson, Sharon Anne; Bell-Higgs, Anna; Craig, Peter; Clement, Nicholas D.; Keerie, Catriona; Kingsbury, Sarah R.; Leeds, Anthony R.; Ross, Hazel M.; Pandit, Hemant G.; Tuck, Chris; Norrie, John

Abstract

Background
Patients’ pre-operative health and physical function is known to influence their post-operative outcomes. 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.

Methods/design
This 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 days 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.

The 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.

Discussion
The 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.

This 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.

Trial registration
ISRCTN registry, ID: ISRCTN96684272. Registered on 18 April 2018.

• Journal Article Type: Article
• Acceptance Date: Sep 7, 2019
• Online Publication Date: Feb 19, 2020
• Publication Date: 2020-12
• Deposit Date: Nov 9, 2020
• Publicly Available Date: Nov 10, 2020
• Journal: Trials
• Print ISSN: 1745-6215
• Publisher: BMC
• Peer Reviewed: Peer Reviewed
• Volume: 21
• Issue: 1
• Article Number: 209 (2020)
• DOI: https://doi.org/10.1186/s13063-019-3709-5
• Public URL: http://researchrepository.napier.ac.uk/Output/2698261