Evidence map›Paper›PMID 29643169›Full record

Trial reportBMJ open2018

Safety and feasibility evaluation of tourniquets for total knee replacement (SAFE-TKR): study protocol.

Peter Dh Wall, Imran Ahmed, Andrew Metcalfe, Andrew J Price, Kate Seers, Charles E Hutchinson, Helen Parsons, Jane Warwick, Bushra Rahman, Jaclyn Brown and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Tourniquet use for knee replacement surgery.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Peter Dh WallWarwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Imran AhmedTrauma and Orthopaedics, University Hospitals Coventry and Warwickshire, Coventry, UK.
Andrew MetcalfeWarwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Andrew J PriceNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Kate SeersRoyal College of Nursing Research Institute, University of Warwick, Coventry, UK.
Charles E HutchinsonWarwick Medical School, University of Warwick, Coventry, UK.
Helen ParsonsWarwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Jane WarwickWarwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Bushra RahmanWarwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Jaclyn BrownWarwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Martin UnderwoodWarwick Clinical Trials Unit, University of Warwick, Coventry, UK.
SAFE-TKR Study Group

Funding

Department of Health PDF-2015-08-108
6 · The paper itself

Abstract

introductionThis 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. 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.

Indexed as

Arthroplasty, Replacement, KneeTourniquetsEnglandHumansResearch DesignTreatment OutcomeWalesadult surgerykneestroke

Identifiers

PMID29643169
PMCPMC5900804

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.