Department of Trauma and Orthopaedics, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
Edinburgh Clinical Trials Unit, University of Edinburgh, Usher Institute, Level 2, Nine Edinburgh BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX, UK.
Trials. 2020 Feb 19;21(1):209. doi: 10.1186/s13063-019-3709-5.
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.
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.
ISRCTN registry, ID: ISRCTN96684272. Registered on 18 April 2018.
患者术前的健康状况和身体功能会影响其术后的结果。在膝关节骨关节炎患者中，在进行关节置换之前，药物和非药物治疗方案往往无法得到优化。这导致一些患者在身体状况不如最佳时接受手术。本研究旨在评估术前非手术治疗方案与关节置换前标准治疗相比的可行性和可接受性。
方法/设计：这是一项针对原发性全膝关节置换术治疗骨关节炎患者的多中心随机对照可行性试验。将招募 60 名患者，并将其随机（2:1）分配至干预组或标准护理组。数据将在基线（干预开始前）、干预期末和计划手术日期后至少 90 天收集。在干预期间，每周将进行一次依从性评估（通过电话或面对面）。参与者将随机分配到术前非手术治疗方案或标准护理组。非手术治疗方案包括：（1）减肥计划；（2）一组运动；（3）提供关于镇痛药使用的建议；（4）提供鞋垫。一旦患者被添加到关节置换手术的等候名单中，就会尽快开始干预，以利用这一激励措施来促进行为改变。本研究的主要结局是可行性结局，这将表明干预和研究方案是否可行和可接受，以及是否需要进行全面的有效性试验。将通过以下措施来测量并告知研究可行性：招募率、计划手术日期后 90 天随访时的保留率，以及通过审查问卷和体重变化（对于接受干预减肥方面的患者）估计的干预依从性。此外，还将评估以下信息：通过定性访谈分析可接受性、可行性、依从性和实施干预的可能障碍，以及不同结局测量的可接受性。
该研究的目的特别涉及测试拟议的有效性试验干预的可行性和可接受性，以及试验方法的可行性。这项研究是开发和评估干预措施是否有潜力在未来的全效试验中进行评估的重要第一步。研究结果还将用于改进有效性试验的设计。
ISRCTN 注册，编号：ISRCTN82157302。于 2018 年 4 月 18 日注册。
