Protocol for a single-centre, parallel-arm, double-blind randomised trial evaluating the effects of tourniquet use in total knee arthroplasty on intra-operative and post-operative outcomes

BACKGROUND: Tourniquet use during total knee replacement is common, yet uncertainty exists regarding its benefits and harms. The primary aim of the current study is to investigate whether tourniquet use during total knee replacement leads to greater reduction in quadriceps strength than non-tourniquet use at three months post-surgery. Secondary aims include investigating the effects of tourniquet use on: quadriceps strength at day 2 and 5, and 12 months post-surgery; pain and analgesia requirements; self-reported physical function and quality of life; blood loss and replacement; surgeon satisfaction with the intra-operative visual field; operation and anaesthetic time; complications; cement mantle quality; patient satisfaction; and hospital length of stay. METHODS: The study is a single centre, parallel-arm, double-blind (participant and assessor), randomised trial with 1:1 random allocation. Participants will be undergo total knee replacement with or without tourniquet. Linear mixed models will be used for group comparisons of continuous outcomes available at multiple timepoints. Other continuous outcomes that are assessed at baseline and once/twice at follow-up will be analysed using linear regression. Categorical outcomes will be analysed using logistic regression models. DISCUSSION: This study will provide high-quality evidence regarding the effects of tourniquet use during total knee replacement, which can be used to inform surgeon decision-making. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000425291 . Retrospectively registered 23 March 2018.