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Clinical and cost-effectiveness of Knee Arthroplasty versus Joint Distraction for Osteoarthritis (KARDS) : protocol for a multicentre, phase III, randomised control trial
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Tassinari, Cerys, Higham, Ruchi, Smith, Isabelle, Arnold, Susanne, Mujica-Mota, Ruben, Metcalfe, Andrew J., Simpson, A. Hamish R. W., Murray, David, McGonagle, Dennis, Sharma, Hemant K., Hamilton, Thomas W., Ellard, David R. , Fernandez, Catherine, Reynolds, Catherine, Harwood, Paul, Croft, Julie, Stocken, Deborah D. and Pandit, Hemant (2022) Clinical and cost-effectiveness of Knee Arthroplasty versus Joint Distraction for Osteoarthritis (KARDS) : protocol for a multicentre, phase III, randomised control trial. BMJ Open, 12 (6). e062721. doi:10.1136/bmjopen-2022-062721 ISSN 2044-6055.
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Official URL: https://doi.org/10.1136/bmjopen-2022-062721
Abstract
Introduction Knee replacement (KR) is a clinically proven procedure typically offered to patients with severe knee osteoarthritis (OA) to relieve pain and improve quality of life. However, artificial joints fail over time, requiring revision associated with higher mortality and inferior outcomes. With more young people presenting with knee OA and increasing life expectancy, there is an unmet need to postpone time to first KR. Knee joint distraction (KJD), the practice of using external fixators to open up knee joint space, is proposed as potentially effective to preserve the joint following initial studies in the Netherlands, however, has not been researched within an NHS setting. The KARDS trial will investigate whether KJD is non-inferior to KR in terms of patient-reported postoperative pain 12 months post-surgery.
Methods and analysis KARDS is a phase III, multicentre, pragmatic, open-label, individually randomised controlled non-inferiority trial comparing KJD with KR in patients with severe knee OA, employing a hybrid-expertise design, with internal pilot phase and process evaluation. 344 participants will be randomised (1:1) to KJD or KR. The primary outcome measure is the Knee Injury and Osteoarthritis Outcomes Score (KOOS) pain domain score at 12 months post-operation. Secondary outcome measures include patient-reported overall KOOS, Pain Visual Analogue Scale and Oxford Knee Scores, knee function assessments, joint space width, complications and further interventions over 24 months post-operation. Per patient cost difference between KR and KJD and cost per quality-adjusted life year (QALY) gained over 24 months will be estimated within trial, and incremental cost per QALY gained over 20 years by KJD relative to KR predicted using decision analytic modelling.
| Item Type: | Journal Article | |||||||||
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Journal or Publication Title: | BMJ Open | |||||||||
| Publisher: | BMJ | |||||||||
| ISSN: | 2044-6055 | |||||||||
| Official Date: | 30 June 2022 | |||||||||
| Dates: |
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| Volume: | 12 | |||||||||
| Number: | 6 | |||||||||
| Article Number: | e062721 | |||||||||
| DOI: | 10.1136/bmjopen-2022-062721 | |||||||||
| Status: | Peer Reviewed | |||||||||
| Publication Status: | Published | |||||||||
| Access rights to Published version: | Open Access (Creative Commons) | |||||||||
| Date of first compliant deposit: | 24 May 2022 | |||||||||
| Date of first compliant Open Access: | 8 July 2022 | |||||||||
| RIOXX Funder/Project Grant: |
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