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Surgery
Protocol
Safety and feasibility evaluation of tourniquets for total knee replacement (SAFE-TKR): study protocol
  1. Peter DH Wall1,
  2. Imran Ahmed2,
  3. Andrew Metcalfe1,
  4. Andrew J Price3,
  5. Kate Seers4,
  6. Charles E Hutchinson5,
  7. Helen Parsons1,
  8. Jane Warwick1,
  9. Bushra Rahman1,
  10. Jaclyn Brown1,
  11. Martin Underwood1
  12. on behalf of the SAFE-TKR Study Group
    1. 1 Warwick Clinical Trials Unit, University of Warwick, Coventry, UK
    2. 2 Trauma and Orthopaedics, University Hospitals Coventry and Warwickshire, Coventry, UK
    3. 3 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
    4. 4 Royal College of Nursing Research Institute, University of Warwick, Coventry, UK
    5. 5 Warwick Medical School, University of Warwick, Coventry, UK
    1. Correspondence to Peter DH Wall; p.d.h.wall{at}warwick.ac.uk

    Abstract

    Introduction This study is designed to determine whether a full randomised controlled trial (RCT) examining the clinical effectiveness and safety of total knee replacement surgery with or without a tourniquet is warranted and feasible.

    Method and analysis Single centre, patient-blinded and assessor-blinded RCT. A computer-generated randomisation service will allocate 50 participants into one of two trial treatments, surgery with or without a tourniquet. The primary objective is to estimate recruitment, crossovers and follow-up of patients. All patients will have an MRI scan of their brain preoperatively and day 1 or 2 postoperatively to identify ischaemic cerebral emboli (primary clinical outcome). Oxford Cognitive Screen, Montreal Cognitive Assessment and Mini-Mental State Examination will be evaluated as outcome tools for measuring cognitive impairment at days 1, 2 and 7 postoperatively. Thigh pain, blood transfusion requirements, venous thromboembolism, revision surgery, surgical complications, mortality and Oxford knee and five-level EuroQol-5D scores will be collected over 12 months. Integrated qualitative research study: 30 trial patients and 20 knee surgeons will take part in semistructured interviews. Interviews will capture views regarding the pilot trial and explore barriers and potential solutions to a full trial. Multicentre cohort study: UK National Joint Registry data will be linked to Hospital Episode Statistics to estimate the relationship between tourniquet use and venous thromboembolic event, length of hospital stay, risk of revision surgery and death. The study will conclude with a multidisciplinary workshop to reach a consensus on whether a full trial is warranted and feasible.

    Ethics and dissemination National Research Ethics Committee (West Midlands-Edgbaston) approved this study on 27 January 2016 (15/WM/0455). The study is sponsored by University of Warwick and University Hospitals Coventry and Warwickshire. The results will be disseminated via high-impact peer-reviewed publication.

    Trial registration number ISRCTN20873088; Pre-results.

    • knee
    • stroke
    • adult surgery

    This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

    https://doi.org/10.1136/bmjopen-2018-022067

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      Footnotes

      • Contributors PDHW: chief investigator, study conception, study design, data collection, drafted and reviewed final manuscript. IA: data collection and drafted and reviewed final manuscript. AM: principal investigator and drafted and reviewed final manuscript. AJP, KS and MU: study design and drafted and reviewed final manuscript. CEH: study design, data analysis and drafted and reviewed final manuscript. HP and JW: data analysis and drafted and reviewed final manuscript. BR and JB: trial manager, data collection and drafted and reviewed final manuscript. SAFE-TKR Study Group: study design and reviewed final manuscript.

      • Funding The study protocol represents research funded by a National Institute for Health Research (NIHR) Post-Doctoral Fellowship Award (PDF-2015-08-108). The study is jointly sponsored by the University of Warwick and University Hospitals Coventry & Warwickshire NHS Trust. The trial sponsors provide ultimate approval of all new versions of the protocol before they become live. Both the funders and sponsors are required to provide final approval before publication of any study material.

      • Disclaimer The study funder and sponsor had no role in the study design; the collection, analysis, or interpretation of data; the writing of the report; or the decision to submit for publication. The researchers are independent and the views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

      • Competing interests None declared.

      • Patient consent Not required.

      • Ethics approval The study trial obtained approval from the National Research Ethics Committee (NRES) West Midlands – Edgbaston (15/WM/0455) on the 27 January 2016. We aim to publish the results in at least one high-impact peer-reviewed journal. The results of the trial will also be disseminated via patient information material produced in collaboration with our Public Patient Involvement group. All key study findings will be presented at national and international conferences, for example, British Orthopaedic Association (BOA), British Association of Specialist Knee Surgeons (BASK) and America Academy of Orthopedic Surgeons (AAOS).

      • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

      • Data sharing statement Requests for access to the final dataset will be overseen by the TSC. Reasonable requests will then be given access to a full anonymised dataset.

      • Collaborators SAFE-TKR Study Group additonal members: Christine Goulden, James Smith, Jan Dixon, Nele Demeyere.