PMID- 33483447
OWN - NLM
STAT- MEDLINE
DCOM- 20210413
LR  - 20210413
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 11
IP  - 1
DP  - 2021 Jan 22
TI  - Tourniquet use in total knee replacement surgery: a feasibility study and pilot 
      randomised controlled trial (SAFE-TKR study).
PG  - e043564
LID - 10.1136/bmjopen-2020-043564 [doi]
LID - e043564
AB  - 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.
CI  - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published 
      by BMJ.
FAU - Wall, Peter David Henry
AU  - Wall PDH
AUID- ORCID: 0000-0003-3149-3373
AD  - Warwick Clinical Trials Unit, University of Warwick Warwick Medical School, 
      Coventry, UK p.d.h.wall@warwick.ac.uk.
FAU - Ahmed, Imran
AU  - Ahmed I
AUID- ORCID: 0000-0003-2774-9954
AD  - Warwick Clinical Trials Unit, University of Warwick Warwick Medical School, 
      Coventry, UK.
FAU - Edwin, Claire
AU  - Edwin C
AD  - Warwick Clinical Trials Unit, University of Warwick Warwick Medical School, 
      Coventry, UK.
FAU - Farhan-Alanie, Muhamed M
AU  - Farhan-Alanie MM
AUID- ORCID: 0000-0002-9209-0108
AD  - Trauma and Orthopaedic, Warwick Clinical Trials Unit, Coventry, UK.
FAU - Parsons, Helen
AU  - Parsons H
AD  - Division of Health Sciences, University of Warwick, Coventry, Warks, UK.
FAU - Price, Andrew James
AU  - Price AJ
AUID- ORCID: 0000-0002-4258-5866
AD  - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, 
      University of Oxford, Oxford, UK.
FAU - Warwick, Jane
AU  - Warwick J
AD  - Warwick Clinical Trials Unit, University of Warwick Warwick Medical School, 
      Coventry, UK.
FAU - Hutchinson, Charles E
AU  - Hutchinson CE
AD  - Warwick Medical School, University of Warwick, Coventry, UK.
FAU - Underwood, Martin
AU  - Underwood M
AD  - Warwick Medical School, University of Warwick, Coventry, UK.
FAU - Metcalfe, Andrew
AU  - Metcalfe A
AUID- ORCID: 0000-0002-4515-8202
AD  - Warwick Clinical Trials Unit, University of Warwick Warwick Medical School, 
      Coventry, UK.
AD  - Trauma and Orthopaedics, University Hospitals Coventry and Warwickshire NHS 
      Trust, Coventry, UK.
CN  - SAFE-TKR Study Group
CN  - the SAFE-TKR study group
LA  - eng
SI  - ISRCTN/ISRCTN20873088
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  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210122
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - Adult
MH  - *Arthroplasty, Replacement, Knee/adverse effects
MH  - Feasibility Studies
MH  - Female
MH  - Humans
MH  - Pilot Projects
MH  - *Tourniquets
MH  - Treatment Outcome
PMC - PMC7825264
OTO - NOTNLM
OT  - adult surgery
OT  - knee
OT  - orthopaedic & trauma surgery
COIS- Competing interests: None declared.
FIR - Rahman, B
IR  - Rahman B
FIR - Brown, J
IR  - Brown J
FIR - Goulden, C
IR  - Goulden C
FIR - Seers, K
IR  - Seers K
FIR - Smith, J
IR  - Smith J
FIR - Demeyere, N
IR  - Demeyere N
FIR - Dixon, J
IR  - Dixon J
EDAT- 2021/01/24 06:00
MHDA- 2021/04/14 06:00
PMCR- 2021/01/22
CRDT- 2021/01/23 05:33
PHST- 2021/01/23 05:33 [entrez]
PHST- 2021/01/24 06:00 [pubmed]
PHST- 2021/04/14 06:00 [medline]
PHST- 2021/01/22 00:00 [pmc-release]
AID - bmjopen-2020-043564 [pii]
AID - 10.1136/bmjopen-2020-043564 [doi]
PST - epublish
SO  - BMJ Open. 2021 Jan 22;11(1):e043564. doi: 10.1136/bmjopen-2020-043564.