Simpson, A. H. R.W. et al. (2024) A preoperative package of care for osteoarthritis, consisting of weight loss, orthotics, rehabilitation, topical and oral analgesia (OPPORTUNITY): A two centre open label randomised controlled feasibility trial. Lancet Rheumatology, (doi: 10.1016/S2665-9913(23)00337-5) (Early Online Publication)
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Abstract
Background Osteoarthritis of the knee is a major cause of disability worldwide. Non-operative treatments can reduce the morbidity but adherence is poor. We hypothesised that adherence could be optimised if behavioural change was established in the preoperative period. Therefore, we aimed to assess feasibility, acceptability, and recruitment and retention rates of a preoperative package of non-operative care in patients awaiting knee replacement surgery. Methods We did an open-label, randomised controlled, feasibility trial in two secondary care centres in the UK. Eligible participants were aged 15–85 years, on the waiting list for a knee arthroplasty for osteoarthritis, and met at least one of the thresholds for one of the four components of the preoperative package of non-operative care intervention (ie, weight loss, exercise therapy, use of insoles, and analgesia adjustment). Participants were randomly assigned (2:1) to either the intervention group or the standard of care (ie, control) group. All four aspects of the intervention were delivered weekly over 12 weeks. Participants in the intervention group were reviewed regularly to assess adherence. The primary outcome was acceptability and feasibility of delivering the intervention, as measured by recruitment rate, retention rate at follow-up review after planned surgery, health-related quality of life, joint-specific scores, and adherence (weight change and qualitative interviews). This study is registered with ISRCTN, ISRCTN96684272. Findings Between Sept 3 2018, and Aug 30, 2019, we screened 233 patients, of whom 163 (73%) were excluded and 60 (27%) were randomly assigned to either the intervention group (n=40) or the control group (n=20). 34 (57%) of 60 participants were women, 26 (43%) were men, and the mean age was 66·8 years (SD 8·6). Uptake of the specific intervention components varied: 31 (78%) of 40 had exercise therapy, 28 (70%) weight loss, 22 (55%) analgesia adjustment, and insoles (18 [45%]). Overall median adherence was 94% (IQR 79·5–100). At the final review, the intervention group lost a mean of 11·2 kg (SD 5·6) compared with 1·3 kg (3·8) in the control group (estimated difference –9·8 kg [95% CI –13·4 to –6·3]). A clinically significant improvement in health-related quality o life (mean change 0·078 [SD 0·195]) were reported, and joint-specific scores showed greater improvement in the intervention group than in the control group. No adverse events attributable to the intervention occurred. Interpretation Participants adhered well to the non-operative interventions and their health-related quality of life improved. Participant and health professional feedback were extremely positive. These findings support progression to a full-scale effectiveness trial.
| Item Type: | Articles |
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| Additional Information: | PGC and SRK are supported in part through the National Institute of Health and Care Research (NIHR) Leeds Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. ShS acknowledges funding support from the UK Medical Research Council and Scottish Chief Scientist Office core funding as part of the MRC/CSO Social and Public Health Sciences Unit ‘Complexity in Health Improvement’ programme (MC_UU_12017/14, MC_UU_00022/1 and SPHSU14, SPHSU16). |
| Status: | Early Online Publication |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Craig, Professor Peter and Mcgarty, Dr Arlene and Smillie, Susie and Simpson, Professor Sharon |
| Authors: | Simpson, A. H. R.W., Clement, N. D., Simpson, S. A., Pandit, H. G., Smillie, S., Leeds, A., Conaghan, P. G., Kingsbury, S. R., Hamilton, D., Craig, P., Ray, D., Keerie, C., Kinsella, E., Bell-Higgs, A., Mcgarty, A., Beadle, C., Howie, C. R., and Norrie, J. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Mental Health and Wellbeing College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU |
| Journal Name: | Lancet Rheumatology |
| Publisher: | Elsevier |
| ISSN: | 2665-9913 |
| ISSN (Online): | 2665-9913 |
| Published Online: | 26 February 2024 |
| Copyright Holders: | Copyright: © 2024 The Author(s) |
| First Published: | First published in Lancet Rheumatology 2024 |
| Publisher Policy: | Reproduced under a Creative Commons licence |
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