PMID- 33316105 OWN - NLM STAT- MEDLINE DCOM- 20210115 LR - 20220922 IS - 1469-493X (Electronic) IS - 1361-6137 (Linking) VI - 12 IP - 12 DP - 2020 Dec 8 TI - Tourniquet use for knee replacement surgery. PG - CD012874 LID - 10.1002/14651858.CD012874.pub2 [doi] LID - CD012874 AB - BACKGROUND: Many surgeons prefer to perform total knee replacement surgery with the aid of a tourniquet. A tourniquet is an occlusive device that restricts distal blood flow to help create a bloodless field during the procedure. A tourniquet may be associated with increased risk of pain and complications. OBJECTIVES: To determine the benefits and harms of tourniquet use in knee replacement surgery. SEARCH METHODS: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) up to 26 March 2020. We searched clinicaltrials.gov, the World Health Organization trials portal, and several international registries and joint registries up to March 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing knee replacement with use of a tourniquet versus without use of a tourniquet and non-randomised studies with more than 1000 participants. Major outcomes included pain, function, global assessment of success, health-related quality of life, serious adverse events (including venous thromboembolism, infection, re-operation, and mortality), cognitive function, and survival of the implant. Minor outcomes included blood loss, economic outcomes, implant stability, and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors screened abstracts and full texts, extracted data, performed risk of bias assessments, and assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 41 RCTs with 2819 participants. Trials included from 20 to 199 participants. Mean age ranged between 58 and 84 years. More than half of the RCTs had unclear risk of selection bias and unclear risk of performance and detection bias due to absence of blinding of participants and surgeons. Major outcomes Pain: at postoperative day 1, pain (on a scale from zero to 10, with higher scores indicating worse pain) was ranked at 4.56 points after surgery without a tourniquet and at 1.25 points (MD) higher (95% CI 0.32 higher to 2.19 higher) with a tourniquet (8 studies; 577 participants), for an absolute difference of 12.5% higher pain scores (95% CI 3.2% higher to 21.9% higher) and a relative difference of 19% higher pain scores (95% CI 3.4% higher to 49% higher) with a tourniquet. Evidence for these findings was of moderate certainty, downgraded due to risk of bias. Knee replacement with a tourniquet probably led to higher postoperative pain scores at day 1, although this difference may or may not be noticeable to patients (based on a minimal clinically important difference (MCID) of 1.0). Function: at 12 months, tourniquet use probably makes little or no difference to function, based on an MCID of 5.3 for Knee Society Score (KSS) and 5.0 for Oxford Knee Score (OKS). Mean function (on a scale from 0 to 100, with higher scores indicating better outcomes) was 90.03 points after surgery without a tourniquet and was 0.29 points worse (95% CI 1.06 worse to 0.48 better) on a 0 to 100 scale, absolute difference was 0.29% worse (1.06% worse to 0.48% better), with a tourniquet (5 studies; 611 participants). This evidence was downgraded to moderate certainty due to risk of bias. Global assessment of success: low-certainty evidence (downgraded due to bias and imprecision) indicates that tourniquet use may have little or no effect on success. At six months, 47 of 50 (or 940 per 1000) reported overall successful treatment after surgery without a tourniquet and 47 of 50 (or 940 per 1000) with a tourniquet (risk ratio (RR) 1.0, 95% CI 0.91 to 1.10) based on one study with 100 participants. Health-related quality of life: at six months, tourniquet may have little or no effect on quality of life. The 12-Item Short Form Survey (SF-12) score (mental component from zero to 100 (100 is best)) was 54.64 after surgery without a tourniquet and 1.53 (MD) better (95% CI 0.85 worse to 3.91 better) with a tourniquet (1 study; 199 participants); absolute difference was 1.53% better (0.85% worse to 3.91% better). Evidence was of low certainty, downgraded due to risk of bias and small number of participants. Serious adverse events: the risk of serious adverse events was probably higher with tourniquet; 26 of 898 (29 per 1000) reported events following surgery without a tourniquet compared to 53 of 901 (59 per 1000) with a tourniquet (RR 1.73, 95% CI 1.10 to 2.73) in 21 studies (1799 participants). Twenty-nine more per 1000 patients (95% CI 3 to 50 more per 1000 patients) had a serious adverse event with a tourniquet. Forty-eight (95% CI 20 to 345) participants would need to have surgery without a tourniquet to avoid one serious adverse event. This evidence was downgraded to moderate certainty due to risk of bias. Cognitive function: one study reported cognitive function as an outcome; however the data were incompletely reported and could not be extracted for analysis. Survival of implant: it is uncertain if tourniquet has an effect on implant survival due to very low certainty evidence (downgraded for bias, and twice due to very low event rates); 2 of 107 (19 per 1000) required revision surgery in the surgery with a tourniquet group compared to 1 of 107 (9 per 1000) without a tourniquet group at up to two years' follow-up (RR 1.44, 95% CI 0.23 to 8.92). This equates to a 0.4% (0.7% lower to 7% more) increased absolute risk in surgery with a tourniquet. AUTHORS' CONCLUSIONS: Moderate certainty evidence shows that knee replacement surgery with a tourniquet is probably associated with an increased risk of serious adverse events. Surgery with a tourniquet is also probably associated with higher postoperative pain, although this difference may or may not be noticeable to patients. Surgery with a tourniquet does not appear to confer any clinically meaningful benefit on function, treatment success or quality of life. Further research is required to explore the effects of tourniquet use on cognitive function and implant survival, to identify any additional harms or benefits. If a tourniquet continues to be used in knee replacement surgery, patients should be informed about the potential increased risk of serious adverse events and postoperative pain. CI - Copyright (c) 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. FAU - Ahmed, Imran AU - Ahmed I AD - Warwick Clinical Trials Unit, University of Warwick, Coventry, UK. FAU - Chawla, Amit AU - Chawla A AD - Warwick Clinical Trials Unit, University of Warwick, Coventry, UK. FAU - Underwood, Martin AU - Underwood M AD - Warwick Clinical Trials Unit, University of Warwick, Coventry, UK. FAU - Price, Andrew J AU - Price AJ AD - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. FAU - Metcalfe, Andrew AU - Metcalfe A AD - Warwick Clinical Trials Unit, University of Warwick, Coventry, UK. FAU - Hutchinson, Charles AU - Hutchinson C AD - Health Sciences, University of Warwick, Coventry, UK. FAU - Warwick, Jane AU - Warwick J AD - Warwick Clinical Trials Unit, University of Warwick, Coventry, UK. FAU - Seers, Kate AU - Seers K AD - Warwick Medical School, University of Warwick, Coventry, UK. FAU - Parsons, Helen AU - Parsons H AD - Warwick Clinical Trials Unit, University of Warwick, Coventry, UK. FAU - Wall, Peter Dh AU - Wall PD AD - Warwick Clinical Trials Unit, University of Warwick, Coventry, UK. LA - eng SI - ClinicalTrials.gov/NCT04016285 GR - DRF-2018-11-ST2-030/DH_/Department of Health/United Kingdom GR - PDF-2015-08-108/DH_/Department of Health/United Kingdom PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Systematic Review DEP - 20201208 PL - England TA - Cochrane Database Syst Rev JT - The Cochrane database of systematic reviews JID - 100909747 SB - IM CIN - Clin Orthop Relat Res. 2021 Mar 1;479(3):445-451. PMID: 33565769 MH - Aged MH - Aged, 80 and over MH - Arthroplasty, Replacement, Knee/*adverse effects/methods MH - Female MH - Humans MH - Male MH - Middle Aged MH - Pain Measurement/methods MH - Pain, Postoperative/diagnosis MH - Prosthesis Failure MH - Quality of Life MH - Randomized Controlled Trials as Topic MH - Selection Bias MH - Tourniquets/*adverse effects MH - Treatment Outcome PMC - PMC8094224 COIS- IA declares funding from NIHR. AC has no conflicts of interest. MU is chief investigator or co-investigator on multiple previous and current research grants from the UK National Institute for Health Research, Arthritis Research UK, and is a co-investigator on grants funded by the Australian NHMRC. He is an NIHR Senior Investigator. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is a director and shareholder of Clinvivo Ltd, which provides electronic data collection for health services research. He is part of an academic partnership with Serco Ltd, funded by the European Social Fund, related to return to work initiatives. He is a co-investigator on two NIHR-funded studies, receiving additional support from Stryker Ltd. He has accepted honoraria for teaching/lecturing from Consortium for Advanced Research Training in Africa (CARTA). He was until 2020 an editor of the NIHR journal series and was a member of the NIHR Journal Editors Group, for which he received a fee. AP is a Consultant Orthopaedic Surgeon who routinely undertakes independent TKR surgery and currently routinely performs TKR surgery with a tourniquet unless patients express a preference or there are contraindications to using a tourniquet. AP undertakes Consultancy work for Zimmer Biomet, but this is unrelated to the subject of this review. AM leads two randomised trials (START:REACTS and RACER), in which HP and MU are co-investigators, which are funded by the National Institute for Health Research (NIHR), in the UK. For both studies, Stryker (USA) is providing devices or costs for delivery of treatment to participating hospitals, although Stryker is not otherwise funding the studies and has no other financial relationship. Contracts are in place to ensure the full independence of the trial team with regard to study design and delivery, analysis, and reporting of results, aligning to the NIHR standard agreement. There is no direct relationship between these studies and the topic of the review. AM is a Consultant Orthopaedic Surgeon who routinely undertakes independent TKR surgery and currently routinely performs TKR surgery with a tourniquet unless patients express a preference or there are contraindications to using a tourniquet. CH has no conflicts of interest. JW declares funding from NIHR. KS has no conflicts of interest. HP declares funding from NIHR and funding in kind from Stryker. PW declared funding from NIHR Fellowship Award PDF-2015-08-108: feasibility research examining the safety of tourniquets used in knee replacement surgery. Santander Latin American Collaboration Award: establishing a research network between Universidad de Chile and University of Warwick in the field of orthopaedic surgery. EDAT- 2020/12/15 06:00 MHDA- 2021/01/16 06:00 PMCR- 2021/12/08 CRDT- 2020/12/14 17:15 PHST- 2020/12/14 17:15 [entrez] PHST- 2020/12/15 06:00 [pubmed] PHST- 2021/01/16 06:00 [medline] PHST- 2021/12/08 00:00 [pmc-release] AID - CD012874.pub2 [pii] AID - 10.1002/14651858.CD012874.pub2 [doi] PST - epublish SO - Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012874. doi: 10.1002/14651858.CD012874.pub2.