Journal article
Safety and feasibility evaluation of tourniquets for total knee replacement (SAFE-TKR): study protocol
- Abstract:
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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.
Methods 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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 254.3KB, Terms of use)
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- Publisher copy:
- 10.1136/bmjopen-2018-022067
Authors
- Publisher:
- BMJ Publishing Group
- Journal:
- BMJ Open More from this journal
- Volume:
- 8
- Issue:
- 4
- Pages:
- e022067
- Publication date:
- 2018-04-10
- Acceptance date:
- 2018-03-01
- DOI:
- EISSN:
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2044-6055
- Pmid:
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29643169
- Language:
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English
- Keywords:
- Pubs id:
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pubs:843420
- UUID:
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uuid:d56c7040-32dc-43de-bad0-b7e356cf6bb5
- Local pid:
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pubs:843420
- Source identifiers:
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843420
- Deposit date:
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2018-05-18
Terms of use
- Copyright holder:
- Price et al
- Copyright date:
- 2018
- Notes:
- © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. 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/
- Licence:
- CC Attribution (CC BY)
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