UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol
Introduction The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminish...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/10/e079328.full |
| _version_ | 1797640484967940096 |
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| author | Martin Underwood Charles E Hutchinson Siobhan Stevens Helen Parsons James Mason Jennifer Smith Julie Bruce Sophie Rees David R Ellard Jane Warwick Andrew Metcalfe Chetan Khatri Henry Nwankwo Peter David Henry Wall Toby Smith Fares Haddad James Griffin Edward T Davis John A Skinner Helen Bradley |
| author_facet | Martin Underwood Charles E Hutchinson Siobhan Stevens Helen Parsons James Mason Jennifer Smith Julie Bruce Sophie Rees David R Ellard Jane Warwick Andrew Metcalfe Chetan Khatri Henry Nwankwo Peter David Henry Wall Toby Smith Fares Haddad James Griffin Edward T Davis John A Skinner Helen Bradley |
| author_sort | Martin Underwood |
| collection | DOAJ |
| description | Introduction The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology.Methods and analysis The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant–assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants’ awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements.Ethics and dissemination The trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners.Trial registration number ISRCTN13374625. |
| first_indexed | 2024-03-11T13:32:35Z |
| format | Article |
| id | doaj.art-8aeeec7cc51d4f2dba80708bf360695a |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-11T13:32:35Z |
| publishDate | 2023-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-8aeeec7cc51d4f2dba80708bf360695a2023-11-02T17:10:07ZengBMJ Publishing GroupBMJ Open2044-60552023-10-01131010.1136/bmjopen-2023-079328UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocolMartin Underwood0Charles E Hutchinson1Siobhan Stevens2Helen Parsons3James Mason4Jennifer Smith5Julie Bruce6Sophie Rees7David R Ellard8Jane Warwick9Andrew Metcalfe10Chetan Khatri11Henry Nwankwo12Peter David Henry Wall13Toby Smith14Fares Haddad15James Griffin16Edward T Davis17John A Skinner18Helen Bradley19University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UKUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK1 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, UKSection of Population Health, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZDBristol Trials Centre, University of Bristol, Bristol, UKUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UKKing’s Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King`s College London, London, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKresearch fellowRoyal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UKWarwick Medical School, University of Warwick, Coventry, UKTrauma & Orthopaedic Surgery, University College London Hospitals NHS Foundation Trust, London, UKUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UKRoyal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UKRoyal National Orthopaedic Hospital NHS Trust, Stanmore, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKIntroduction The number of robotic-assisted hip replacement procedures has expanded globally with the intended aim of improving outcomes. Intraoperative robotic-arm systems add additional costs to total hip replacement (THR) surgery but may improve surgical precision and could contribute to diminished pain and improved function. Additionally, these systems may reduce the need for expensive revision surgery. Surgery with conventional instruments may be just as successful, quick and affordable. There is timely demand for a robust evaluation of this technology.Methods and analysis The Robotic Arthroplasty Clinical and cost Effectiveness Randomised controlled trial for Hips (RACER-Hip) is a multicentre (minimum of six UK sites), participant–assessor blinded, randomised controlled trial. 378 participants with hip osteoarthritis requiring THR will be randomised (1:1) to receive robotic-assisted THR, or THR using conventional surgical instruments. The primary outcome is the Forgotten Joint Score at 12 months post-randomisation; a patient-reported outcome measure assessing participants’ awareness of their joint when undertaking daily activities. Secondary outcomes will be collected post-operatively (pain, blood loss and opioid usage) and at 3, 6, 12, 24 months, then 5 and 10 years postrandomisation (including function, pain, health-related quality of life, reoperations and satisfaction). Allocation concealment will be accomplished using a computer-based randomisation procedure on the day of surgery. Blinding methods include the use of sham incisions for marker clusters and blinded operation notes. The primary analysis will adhere to the intention-to-treat principle. Results will adhere to Consolidated Standards of Reporting Trials statements.Ethics and dissemination The trial was approved by an ethics committee (Solihull Research Ethics Committee, 30 June 2021, IRAS: 295831). Participants will provide informed consent before agreeing to participate. Results will be disseminated using peer-reviewed journal publications, presentations at international conferences and through the use of social media. We will develop plans to disseminate to patients and public with our patient partners.Trial registration number ISRCTN13374625.https://bmjopen.bmj.com/content/13/10/e079328.full |
| spellingShingle | Martin Underwood Charles E Hutchinson Siobhan Stevens Helen Parsons James Mason Jennifer Smith Julie Bruce Sophie Rees David R Ellard Jane Warwick Andrew Metcalfe Chetan Khatri Henry Nwankwo Peter David Henry Wall Toby Smith Fares Haddad James Griffin Edward T Davis John A Skinner Helen Bradley UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol BMJ Open |
| title | UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol |
| title_full | UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol |
| title_fullStr | UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol |
| title_full_unstemmed | UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol |
| title_short | UK robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips (RACER-Hip): a study protocol |
| title_sort | uk robotic arthroplasty clinical and cost effectiveness randomised controlled trial for hips racer hip a study protocol |
| url | https://bmjopen.bmj.com/content/13/10/e079328.full |
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