Current developments in robotic assistance technology for total knee arthroplasty: a comprehensive overview.

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Abstract

[Indexed for MEDLINE] Conflict of interest statement: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests. 11. BMJ Open. 2023 Jun 9;13(6):e068255. doi: 10.1136/bmjopen-2022-068255. Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol. Griffin J(1)(2), Davis ET(3), Parsons H(4)(2), Gemperle Mannion E(4), Khatri C(4)(2), Ellard DR(4)(2), Blyth MJ(5), Clement ND(6)(7), Deehan D(8), Flynn N(9), Fox J(10), Grant NJ(10), Haddad FS(11), Hutchinson CE(2)(12), Mason J(4), Mohindru B(4), Scott CEH(13)(14), Smith TO(4), Skinner JA(15), Toms AD(16), Rees S(17), Underwood M(4)(2), Metcalfe A(4)(2). Author information: (1)Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK James.Griffin@warwick.ac.uk. (2)University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK. (3)Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK. (4)Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK. (5)Orthopaedic Research Unit, Department of Trauma and Orthopaedics, Glasgow Royal Infirmary, Glasgow, UK. (6)Orthopaedics and Trauma, Royal Infirmary of Edinburgh, Edinburgh, UK. (7)Department of Orthopaedics, University of Edinburgh Division of Clinical and Surgical Sciences, Edinburgh, UK. (8)Newcastle Upon Tyne Hospitals NHS Trust, Newcastle Upon Tyne, UK. (9)Portsmouth Hospitals NHS Trust, Portsmouth, UK. (10)Patient Representative, Coventry, UK. (11)University College London Hospitals NHS Foundation Trust, London, UK. (12)Warwick Medical School, University of Warwick, Coventry, UK. (13)Department of Orthopaedics, Royal Infirmary of Edinburgh, Edinburgh, UK. (14)University of Edinburgh Division of Clinical and Surgical Sciences, Edinburgh, UK. (15)Royal National Orthopaedic Hospital NHS Trust, Stanmore, UK. (16)Royal Devon and Exeter NHS Foundation Trust, Exeter, UK. (17)Bristol Trials Centre, University of Bristol, Bristol, UK. Erratum in BMJ Open. 2023 Sep 20;13(9):e068255corr1. doi: 10.1136/bmjopen-2022-068255corr1. INTRODUCTION: Robotic-assisted knee replacement systems have been introduced to healthcare services worldwide in an effort to improve clinical outcomes for people, although high-quality evidence that they are clinically, or cost-effective remains sparse. Robotic-arm systems may improve surgical accuracy and could contribute to reduced pain, improved function and lower overall cost of total knee replacement (TKR) surgery. However, TKR with conventional instruments may be just as effective and may be quicker and cheaper. There is a need for a robust evaluation of this technology, including cost-effectiveness analyses using both within-trial and modelling approaches. This trial will compare robotic-assisted against conventional TKR to provide high-quality evidence on whether robotic-assisted knee replacement is beneficial to patients and cost-effective for healthcare systems. METHODS AND ANALYSIS: The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial-Knee is a multicentre, participant-assessor blinded, randomised controlled trial to evaluate the clinical and cost-effectiveness of robotic-assisted TKR compared with TKR using conventional instruments. A total of 332 participants will be randomised (1:1) to provide 90% power for a 12-point difference in the primary outcome measure; the Forgotten Joint Score at 12 months postrandomisation. Allocation concealment will be achieved using computer-based randomisation performed on the day of surgery and methods for blinding will include sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will be reported in line with the Consolidated Standards of Reporting Trials statement. A parallel study will collect data on the learning effects associated with robotic-arm systems. ETHICS AND DISSEMINATION: The trial has been approved by an ethics committee for patient participation (East Midlands-Nottingham 2 Research Ethics Committee, 29 July 2020. NRES number: 20/EM/0159). All results from the study will be disseminated using peer-reviewed publications, presentations at international conferences, lay summaries and social media as appropriate. TRIAL REGISTRATION NUMBER: ISRCTN27624068. © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. DOI: 10.1136/bmjopen-2022-068255 PMCID: PMC10277111