Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol
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 accur...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/6/e068255.full |
| _version_ | 1797679666513838080 |
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| author | Martin Underwood Charles E Hutchinson Helen Parsons James Mason Toby O Smith Sophie Rees David R Ellard Andrew Metcalfe Elke Gemperle Mannion Josephine Fox David Deehan Chetan Khatri Fares S Haddad James Griffin Andrew D Toms Nicholas David Clement Edward T Davis Mark J Blyth Nicholas Flynn Nicholas J Grant Bishal Mohindru Chloe E H Scott John A Skinner |
| author_facet | Martin Underwood Charles E Hutchinson Helen Parsons James Mason Toby O Smith Sophie Rees David R Ellard Andrew Metcalfe Elke Gemperle Mannion Josephine Fox David Deehan Chetan Khatri Fares S Haddad James Griffin Andrew D Toms Nicholas David Clement Edward T Davis Mark J Blyth Nicholas Flynn Nicholas J Grant Bishal Mohindru Chloe E H Scott John A Skinner |
| author_sort | Martin Underwood |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T23:18:11Z |
| format | Article |
| id | doaj.art-001910fc6fdc4090adedb824dc00e8ac |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-11T23:18:11Z |
| publishDate | 2023-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-001910fc6fdc4090adedb824dc00e8ac2023-09-20T17:50:06ZengBMJ Publishing GroupBMJ Open2044-60552023-06-0113610.1136/bmjopen-2022-068255Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocolMartin Underwood0Charles E Hutchinson1Helen Parsons2James Mason3Toby O Smith4Sophie Rees5David R Ellard6Andrew Metcalfe7Elke Gemperle Mannion8Josephine Fox9David Deehan10Chetan Khatri11Fares S Haddad12James Griffin13Andrew D Toms14Nicholas David Clement15Edward T Davis16Mark J Blyth17Nicholas Flynn18Nicholas J Grant19Bishal Mohindru20Chloe E H Scott21John A Skinner22University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UKUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKBristol Trials Centre, University of Bristol, Bristol, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKPatient Representative, Coventry, UKNewcastle Upon Tyne Hospitals NHS Trust, Newcastle Upon Tyne, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKUniversity College London Hospitals NHS Foundation Trust, London, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKRoyal Devon and Exeter NHS Foundation Trust, Exeter, UKOrthopaedics and Trauma, Royal Infirmary of Edinburgh, Edinburgh, UKRoyal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UKOrthopaedic Research Unit, Department of Trauma and Orthopaedics, Glasgow Royal Infirmary, Glasgow, UKPortsmouth Hospitals NHS Trust, Portsmouth, UKPatient Representative, Coventry, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKDepartment of Orthopaedics, Royal Infirmary of Edinburgh, Edinburgh, UKRoyal National Orthopaedic Hospital NHS Trust, Stanmore, UKIntroduction 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.https://bmjopen.bmj.com/content/13/6/e068255.full |
| spellingShingle | Martin Underwood Charles E Hutchinson Helen Parsons James Mason Toby O Smith Sophie Rees David R Ellard Andrew Metcalfe Elke Gemperle Mannion Josephine Fox David Deehan Chetan Khatri Fares S Haddad James Griffin Andrew D Toms Nicholas David Clement Edward T Davis Mark J Blyth Nicholas Flynn Nicholas J Grant Bishal Mohindru Chloe E H Scott John A Skinner Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol BMJ Open |
| title | Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol |
| title_full | Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol |
| title_fullStr | Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol |
| title_full_unstemmed | Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol |
| title_short | Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial (RACER-knee): a study protocol |
| title_sort | robotic arthroplasty clinical and cost effectiveness randomised controlled trial racer knee a study protocol |
| url | https://bmjopen.bmj.com/content/13/6/e068255.full |
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