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      Assessing the non-inferiority of prosthesis constructs used in total and unicondylar knee replacements using data from the National Joint Registry of England, Wales, Northern Ireland and the Isle of Man: a benchmarking study

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          Abstract

          Objectives

          To investigate the relative performance of knee replacement constructs compared with the best performing construct and illustrate the substantial variability in performance.

          Design

          A non-inferiority study.

          Setting

          England and Wales.

          Participants

          All primary total and unicondylar knee replacements performed and registered in the National Joint Registry between 1 April 2003 and 31 December 2016.

          Main outcome measures

          Kaplan-Meier failure function for knee replacement constructs. Failure difference between best performing construct (the benchmark) and other constructs.

          Methods

          Using a non-inferiority analysis, the performance of knee replacement constructs by brand were compared with the best performing construct. Construct failure was estimated using the 1-Kaplan Meier method, that is, an estimate of net failure. The difference in failure between the contemporary benchmark construct and all other constructs were tested.

          Results

          Of the 449 different knee replacement constructs used, only 27 had ≥500 procedures at risk at 10 years postprimary, 18 of which were classified as inferior to the benchmark by at least 20% relative risk of failure. Two of these 18 were unicondylar constructs that were inferior by at least 100% relative risk. In men, aged 55–75 years, 12 of 27 (44%) constructs were inferior by at least 20% to the benchmark at 7 years postprimary. In women, aged 55–75 years, 8 of 32 (25%) constructs were inferior at 7 years postprimary. Very few constructs were classified as non-inferior to the contemporary benchmark.

          Conclusions

          There are few knee replacement constructs that can be shown to be non-inferior to a contemporary benchmark. Unicondylar knee constructs have, almost universally, at least 100% worse revision outcomes compared with the best performing total knee replacement. These results will help to inform patients, clinicians and commissioners when considering knee replacement surgery.

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          Most cited references10

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          45-day mortality after 467,779 knee replacements for osteoarthritis from the National Joint Registry for England and Wales: an observational study.

          Understanding the risk factors for early death after knee replacement could help to reduce the risk of mortality after this procedure. We assessed secular trends in death within 45 days of knee replacement for osteoarthritis in England and Wales, with the aim of investigating whether any change that we recorded could be explained by alterations in modifiable perioperative factors.
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            Methods for equivalence and noninferiority testing.

            Classical hypothesis testing focuses on testing whether treatments have differential effects on outcome. However, sometimes clinicians may be more interested in determining whether treatments are equivalent or whether one has noninferior outcomes. We review the hypotheses for these noninferiority and equivalence research questions, consider power and sample size issues, and discuss how to perform such a test for both binary and survival outcomes. The methods are illustrated on 2 recent studies in hematopoietic cell transplantation.
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              • Article: not found

              Larger range of motion and increased return to activity, but higher revision rates following unicompartmental versus total knee arthroplasty in patients under 65: a systematic review

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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2019
                29 April 2019
                : 9
                : 4
                : e026736
                Affiliations
                [1 ] departmentMusculoskeletal Research Unit, Translational Health Sciences , University of Bristol , Bristol, UK
                [2 ] departmentNational Institute for Health Research, Bristol Biomedical Research Centre , University Hospitals Bristol NHS Foundation Trust and University of Bristol , Bristol, UK
                [3 ] departmentCentre for Hip Surgery , Wrightington Hospital , Wigan, UK
                [4 ] departmentPopulation Health Sciences, Bristol Medical School , University of Bristol , Bristol, UK
                Author notes
                [Correspondence to ] Adrian Sayers; adrian.sayers@ 123456bristol.ac.uk
                Author information
                http://orcid.org/0000-0002-9467-0798
                http://orcid.org/0000-0003-2436-9024
                http://orcid.org/0000-0001-7452-5043
                Article
                bmjopen-2018-026736
                10.1136/bmjopen-2018-026736
                6502008
                31036709
                966dbabe-f920-423d-a33c-adce44e029dc
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

                History
                : 19 September 2018
                : 25 January 2019
                : 25 March 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000265, Medical Research Council;
                Categories
                Surgery
                Research
                1506
                1737
                Custom metadata
                unlocked

                Medicine
                knee arthroplasty,non-inferiority,national joint registry,benchmarking,medical devices
                Medicine
                knee arthroplasty, non-inferiority, national joint registry, benchmarking, medical devices

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