Abstract
BackgroundTourniquet 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.MethodsThe 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12618000425291. Retrospectively registered 23 March 2018.
Highlights
Tourniquet use during total knee replacement is common, yet uncertainty exists regarding its benefits and harms
Tourniquet use increased the risk of thrombotic events such as deep vein thrombosis (DVT) and pulmonary embolism (PE) (risk ratio (RR) 5.00; 95% CI, 1.31 to 19.10), and non-thrombotic complications such as reoperation, haematoma, or nerve palsy (RR, 2.03; 95% CI, 1.12 to 3.67)
Dennis et al [17] found tourniquet patients had less isometric quadriceps strength when assessed with a force transducer at three weeks and three months post Total knee replacement (TKR) compared to non-tourniquet patients
Summary
Study design The study is a single centre, parallel-arm, double-blinded (participant and assessor), randomised trial with 1:1 random allocation. All patients attending the study-site for pre-operative assessment for TKR will be assessed for eligibility by the surgeon, orthopaedic registrar or research coordinator. Research assistants will attempt to contact participants a maximum of four times over a three-month period using phone, email or mail before they are considered lost to follow-up. We will collect information relating to adverse events from randomisation until the participant completes the 12 month post-operative assessment. To the best of the our knowledge, at the time of study development there was no published data reporting quadriceps strength following tourniquet use and total knee replacement that could be used to estimate a sample size for this study. Ethics and dissemination Barwon Health Human Research Ethics Committee, Geelong, Australia approved the study including the protocol and the participant information and consent form (reference 11/89). Authorship eligibility for disseminated material will be determined according to international criteria [40]
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