Abstract
IntroductionRobotic-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 analysisThe 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 disseminationThe 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 numberISRCTN27624068.
Funder
Health Technology Assessment Programme
Reference61 articles.
1. AOANJRR . Australian Orthopaedic Association national joint replacement Registry (AOANJRR) hip, knee & shoulder Arthroplasty: 2021 annual report. 2021. Available: https://aoanjrr.sahmri.com/annual-reports-2021
2. National Commitee . National joint Registry for England, Wales, Northern Ireland and the isle of man: 15th annual report, 2017. National Joint Registry Centre 2018.
3. Functional outcome and patient satisfaction in total knee patients over the age of 75
4. Patient Satisfaction after Total Knee Arthroplasty: Who is Satisfied and Who is Not?
5. Health-related quality of life after knee replacement. results of the knee replacement patient outcomes research team study;Hawker;Jbjs,1998
Cited by
4 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献