Wall Peter Dh, Ahmed Imran, Metcalfe Andrew, Price Andrew J, Seers Kate, Hutchinson Charles E, Parsons Helen, Warwick Jane, Rahman Bushra, Brown Jaclyn, Underwood Martin
Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Trauma and Orthopaedics, University Hospitals Coventry and Warwickshire, Coventry, UK.
BMJ Open. 2018 Apr 10;8(4):e022067. doi: 10.1136/bmjopen-2018-022067.
This study is designed to determine whether a full randomised controlled trial (RCT) examining the clinical effectiveness and safety of total knee replacement surgery with or without a tourniquet is warranted and feasible.
Single centre, patient-blinded and assessor-blinded RCT. A computer-generated randomisation service will allocate 50 participants into one of two trial treatments, surgery with or without a tourniquet. The primary objective is to estimate recruitment, crossovers and follow-up of patients. All patients will have an MRI scan of their brain preoperatively and day 1 or 2 postoperatively to identify ischaemic cerebral emboli (primary clinical outcome). Oxford Cognitive Screen, Montreal Cognitive Assessment and Mini-Mental State Examination will be evaluated as outcome tools for measuring cognitive impairment at days 1, 2 and 7 postoperatively. Thigh pain, blood transfusion requirements, venous thromboembolism, revision surgery, surgical complications, mortality and Oxford knee and five-level EuroQol-5D scores will be collected over 12 months. : 30 trial patients and 20 knee surgeons will take part in semistructured interviews. Interviews will capture views regarding the pilot trial and explore barriers and potential solutions to a full trial. : UK National Joint Registry data will be linked to Hospital Episode Statistics to estimate the relationship between tourniquet use and venous thromboembolic event, length of hospital stay, risk of revision surgery and death. The study will conclude with a multidisciplinary workshop to reach a consensus on whether a full trial is warranted and feasible.
National Research Ethics Committee (West Midlands-Edgbaston) approved this study on 27 January 2016 (15/WM/0455). The study is sponsored by University of Warwick and University Hospitals Coventry and Warwickshire. The results will be disseminated via high-impact peer-reviewed publication.
ISRCTN20873088; Pre-results.
本研究旨在确定对使用或不使用止血带的全膝关节置换手术的临床有效性和安全性进行全面随机对照试验（RCT）是否必要且可行。
单中心、患者盲法和评估者盲法的RCT。计算机生成的随机化服务将把50名参与者分配到两种试验治疗方法之一，即使用或不使用止血带的手术。主要目的是估计患者的招募、交叉情况和随访情况。所有患者在术前以及术后第1天或第2天均需进行脑部MRI扫描，以识别缺血性脑栓塞（主要临床结局）。牛津认知筛查、蒙特利尔认知评估和简易精神状态检查将作为术后第1天、第2天和第7天测量认知障碍的结局工具进行评估。在12个月内收集大腿疼痛、输血需求、静脉血栓栓塞、翻修手术、手术并发症、死亡率以及牛津膝关节评分和五级欧洲五维健康量表评分。30名试验患者和20名膝关节外科医生将参与半结构化访谈。访谈将收集关于试点试验的看法，并探讨全面试验的障碍及潜在解决方案。英国国家关节注册数据将与医院事件统计数据相链接，以估计止血带使用与静脉血栓栓塞事件、住院时间、翻修手术风险和死亡之间的关系。该研究将以多学科研讨会结束，就是否有必要且可行进行全面试验达成共识。
国家研究伦理委员会（西米德兰兹 - 埃奇巴斯顿）于2016年1月27日批准了本研究（15/WM/0455）。本研究由华威大学以及考文垂和沃里克郡大学医院赞助。研究结果将通过高影响力的同行评审出版物进行传播。
ISRCTN20873088；预结果。
