Tourniquet use in total knee replacement surgery: a feasibility study and pilot randomised controlled trial (SAFE-TKR study)
Open Access
- 22 January 2021
- Vol. 11 (1), e043564
- https://doi.org/10.1136/bmjopen-2020-043564
Abstract
Introduction Tourniquets are routinely used during total knee replacement (TKR) surgery. They could increase the risk of thromboembolic events including cerebral emboli, cognitive decline, pain and other adverse events (AEs). A randomised controlled trial to assess whether tourniquet use might safely be avoided is therefore warranted but it is unclear whether such a trial would be feasible. Methods In a single-site feasibility study and pilot randomised controlled trial, adults having a TKR were randomised to surgery with an inflated tourniquet versus a non-inflated tourniquet. Participants underwent brain MRI preoperatively and within 2 days postoperatively. We assessed cognition using the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Oxford Cognitive Screen (OCS) and thigh pain using a Visual Analogue Scale at baseline and days 1 and 2, and 1 week postsurgery. AEs related to surgery were recorded up to 12 months. Results We randomised 53 participants (27 tourniquet inflated and 26 tourniquet not inflated). Fifty-one participants received care per-protocol (96%) and 48 (91%) were followed up at 12 months. One new ischaemic brain lesion was detected. Of the cognitive tests, MoCA was easy to summarise, sensitive to change with lower ceiling effects compared with OCS and MMSE. There was a trend towards more thigh pain (mean 49.6 SD 30.4 vs 36.2 SD 28 at day 1) and more AEs related to surgery (21 vs 9) in participants with an inflated tourniquet compared with those with a tourniquet not inflated. Conclusion A full trial is feasible, but using MRI as a primary outcome is unlikely to be appropriate or feasible. Suitable primary outcomes would be cognition measured using MoCA, pain and AEs, all of which warrant investigation in a large multicentre trial. Trial registration number ISRCTN20873088.Keywords
Funding Information
- Research Trainees Coordinating Centre (PDF-2015-08-108)
This publication has 24 references indexed in Scilit:
- Surgical Incision-Induced Nociception Causes Cognitive Impairment and Reduction in Synaptic NMDA Receptor 2B in MiceJournal of Neuroscience, 2013
- The Problem With Asymptomatic Cerebral Embolic Complications in Vascular ProceduresJournal of the American College of Cardiology, 2012
- A Comparison of Outcomes With and Without a Tourniquet in Total Knee Arthroplasty: A Systematic Review and Meta-analysis of Randomized Controlled TrialsThe Journal of Arthroplasty, 2012
- Diffusion-weighted MRI determined cerebral embolic infarction following transcatheter aortic valve implantation: assessment of predictive risk factors and the relationship to subsequent health statusHeart, 2011
- Tourniquet use in total knee arthroplasty: a meta-analysisKnee Surgery, Sports Traumatology, Arthroscopy, 2010
- The prevalence of cognitive dysfunction after conventional and computer-assisted total knee replacementThe Knee, 2010
- Cerebral Microembolization during Primary Total Hip Arthroplasty and Neuropsychologic Outcome: A Pilot StudyClinical Orthopaedics and Related Research, 2010
- Risk and Fate of Cerebral Embolism After Transfemoral Aortic Valve ImplantationJournal of the American College of Cardiology, 2010
- Design and analysis of pilot studies: recommendations for good practiceJournal of Evaluation in Clinical Practice, 2004
- Cerebral Microembolism Diagnosed by Transcranial Doppler during Total Knee ArthroplastyAnesthesiology, 1999