1. Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol.
- Author
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Griffin J, Davis ET, Parsons H, Gemperle Mannion E, Khatri C, Ellard DR, Blyth MJ, Clement ND, Deehan D, Flynn N, Fox J, Grant NJ, Haddad FS, Hutchinson CE, Mason J, Mohindru B, Scott CEH, Smith TO, Skinner JA, Toms AD, Rees S, Underwood M, and Metcalfe A
- Subjects
- Humans, Cost-Effectiveness Analysis, Knee Joint, Pain, Cost-Benefit Analysis, Treatment Outcome, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Robotic Surgical Procedures, Arthroplasty, Replacement, Knee methods
- Abstract
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., Competing Interests: Competing interests: Stryker is providing funding for consumables, preoperative CT costs and 10 min of theatre time, according to contractual arrangements. They also fund some postoperative CT costs in the learning effects study. Appropriate contracts are in place to ensure the independence of the trial team with regard to study design, data collection, management, analysis and interpretation in line with NIHR reporting standards. Multiple investigators are investigators on two other NIHR-funded studies receiving additional support for treatment costs from Stryker, START:REACTS (16/61/18) (AM, HP, CEH, JM and MU) and RACER-Hip (NIHR131407) (AM, ETD, HP, SR, CEH, DRE, JM, FSH, JAS and MU). The full independence of the investigators of these related studies are protected by legal agreements, similar to this study. FSH receives funding from Stryker to run clinical studies. Multiple authors report other unrelated research grants from NIHR during the conduct of the study. DRE, HP and JG are supported from NIHR Research Capability Funding via University Hospitals Coventry and Warwickshire. MU is chief investigator or coinvestigator on multiple previous and current research grants from the UK National Institute for Health Research, Arthritis Research UK and is a coinvestigator on grants funded by the Australian NHMRC and Norwegian MRC. He was an NIHR Senior Investigator until March 2021. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is a director and shareholder of Clinvivo that provides electronic data collection for health services research. He is part of an academic partnership with Serco Ltd, funded by the European Social Fund, related to return to work initiatives. Until March 2020 he was an editor of the NIHR journal series, and a member of the NIHR Journal Editors Group, for which he received a fee., (© 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.)
- Published
- 2023
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