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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Richard S. Page, Simon Williams, Avanthi Selvaratnam, Shaun Waring, Myles Conroy, Andrew Thomson, Sally Beattie, Rekha Ganeshalingam, Stephen D. Gill

Published in: BMC Musculoskeletal Disorders | Issue 1/2018

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Abstract

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 ACTRN12618000425​291. Retrospectively registered 23 March 2018.
Literature
1.
Pabinger C, Lothaller H, Geissler A. Utilization rates of knee-arthroplasty in OECD countries. Osteoarthr Cartil. 2015;23(10):1664–73.CrossRef
2.
National Joint Registry for England and Wales 1st Annual Report. Hemel Hempstead. England: National Joint Registry for England and Wales; 2004.
3.
Berry DJ, Bozic KJ. Current practice patterns in primary hip and knee arthroplasty among members of the American Association of hip and Knee Surgeons. J Arthroplast. 2010;25(6 Suppl):2–4.CrossRef
4.
Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014;9(1):13.CrossRefPubMedPubMedCentral
5.
Mayer C, Franz A, Harmsen JF, Queitsch F, Behringer M, Beckmann J, Krauspe R, Zilkens C. Soft-tissue damage during total knee arthroplasty: focus on tourniquet-induced metabolic and ionic muscle impairment. J Orthop. 2017;14(3):347–53.CrossRefPubMedPubMedCentral
6.
7.
Rathod P, Deshmukh A, Robinson J, Greiz M, Ranawat A, Rodriguez J. Does tourniquet time in primary Total knee arthroplasty influence clinical recovery? J Knee Surg. 2015;28(4):335–42.PubMed
8.
Pfitzner T, von Roth P, Voerkelius N, Mayr H, Perka C, Hube R. Influence of the tourniquet on tibial cement mantle thickness in primary total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2016;24(1):96–101.CrossRefPubMed
9.
Ledin H, Aspenberg P, Good L. Tourniquet use in total knee replacement does not improve fixation, but appears to reduce final range of motion. Acta Orthop. 2012;83(5):499–503.CrossRefPubMedPubMedCentral
10.
Abdel-Salam A, Eyres KS. Effects of tourniquet during total knee arthroplasty. A prospective randomised study. J Bone Joint Surg Br. 1995;77(2):250–3.CrossRefPubMed
11.
Ejaz A, Laursen AC, Kappel A, Laursen MB, Jakobsen T, Rasmussen S, Nielsen PT. Faster recovery without the use of a tourniquet in total knee arthroplasty. Acta Orthop. 2014;85(4):422–6.CrossRefPubMedPubMedCentral
12.
Greene KA, Schurman JR 2nd. Quadriceps muscle function in primary total knee arthroplasty. J Arthroplast. 2008;23(7 Suppl):15–9.CrossRef
13.
Silva M, Shepherd EF, Jackson WO, Pratt JA, McClung CD, Schmalzried TP. Knee strength after total knee arthroplasty. J Arthroplast. 2003;18(5):605–11.CrossRef
14.
Meier W, Mizner RL, Marcus RL, Dibble LE, Peters C, Lastayo PC. Total knee arthroplasty: muscle impairments, functional limitations, and recommended rehabilitation approaches. J Orthop Sports Phys Ther. 2008;38(5):246–56.CrossRefPubMed
15.
Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005;87(5):1047–53.CrossRefPubMed
16.
Liu D, Graham D, Gillies K, Gillies RM. Effects of tourniquet use on quadriceps function and pain in total knee arthroplasty. Knee Surg Relat Res. 2014;26(4):207–13.CrossRefPubMedPubMedCentral
17.
Dennis DA, Kittelson AJ, Yang CC, Miner TM, Kim RH, Stevens-Lapsley JE. Does tourniquet use in TKA affect recovery of lower extremity strength and function? A Randomized Trial. Clin Orthop Relat Res. 2016;474(1):69–77.CrossRefPubMed
18.
Appell HJ, Gloser S, Duarte JA, Zellner A, Soares JM. Skeletal muscle damage during tourniquet-induced ischaemia. The initial step towards atrophy after orthopaedic surgery? Eur J Appl Physiol Occup Physiol. 1993;67(4):342–7.CrossRefPubMed
19.
Tombaugh TN, McIntyre NJ. The mini-mental state examination: a comprehensive review. J Am Geriatr Soc. 1992;40(9):922–35.CrossRefPubMed
20.
Medical Device Solutions: IsoForceControl Dynamometer. Oberburg, Switzerland.
21.
Gagnon D, Nadeau S, Gravel D, Robert J, Belanger D, Hilsenrath M. Reliability and validity of static knee strength measurements obtained with a chair-fixed dynamometer in subjects with hip or knee arthroplasty. Arch Phys Med Rehabil. 2005;86(10):1998–2008.CrossRefPubMed
22.
23.
Bristow PJ, Hillman KM, Chey T, Daffurn K, Jacques TC, Norman SL, Bishop GF, Simmons EG. Rates of in-hospital arrests, deaths and intensive care admissions: the effect of a medical emergency team. Med J Aust. 2000;173(5):236–40.PubMed
24.
Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the knee society clinical rating system. Clin Orthop Relat Res. 1989;248:13–4.
25.
Murray DW, Fitzpatrick R, Rogers K, Pandit H, Beard DJ, Carr AJ, Dawson J. The use of the Oxford hip and knee scores. J Bone Joint Surg Br. 2007;89(8):1010–4.CrossRefPubMed
26.
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833–40.PubMed
27.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.CrossRefPubMedPubMedCentral
28.
Ewald FC. The knee society total knee arthroplasty roentgenographic evaluation and scoring system. Clin Orthop Relat Res. 1989;248:9–12.
29.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.CrossRefPubMed
30.
Owens WD, Felts JA, Spitznagel EL Jr. ASA physical status classifications: a study of consistency of ratings. Anesthesiology. 1978;49(4):239–43.CrossRefPubMed
31.
Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011;173(6):676–82.CrossRefPubMed
32.
Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141(10):781–8.CrossRefPubMed
33.
Stroup WW. Generalized linear mixed models: modern concepts, methods and applications. Boca Raton: CRC Press; 2016.
34.
Rogers WH. Regression standard errors in clustered samples. Stata Tech Bull. 1993;13:19–23.
35.
Hosmer DW Jr, Lemeshow S, Sturdivant RX. Applied logistic regression. New York: John Wiley & Sons; 2013.CrossRef
36.
Gardner W, Mulvey EP, Shaw EC. Regression analyses of counts and rates: Poisson, overdispersed Poisson, and negative binomial models. Psychol Bull. 1995;118(3):392–404.CrossRefPubMed
37.
Mukaka MM. Statistics corner: a guide to appropriate use of correlation coefficient in medical research. Malawi Med J. 2012;24(3):69–71.PubMedPubMedCentral
38.
National Statement on Ethical Conduct in Human Research 2007 (updated May 2015). The National Health and Medical Research Council, the Australian Research Council and the Australian Vice-Chancellors' Committee. Canberra: Commonwealth of Australia.
39.
40.
Metadata
Title
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
Authors
Richard S. Page
Simon Williams
Avanthi Selvaratnam
Shaun Waring
Myles Conroy
Andrew Thomson
Sally Beattie
Rekha Ganeshalingam
Stephen D. Gill
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2018
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-018-2352-8

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