Search

Objectives: To evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy., Design: A prospective, single-blind, two-arm randomised controlled superiority trial., Setting: 14 National Health Service physiotherapy departments in the UK., Participants: 621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool., Interventions: A multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy., Main Outcome Measures: The primary outcome was the Late-Life Function and Disability Instrument (LLFDI) at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function), Knee injury and Osteoarthritis Outcome Score Quality of Life subscale, Physical Activity Scale for the Elderly, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance., Results: 621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4-7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2-6). The primary outcome, LLFDI function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference=0.49 points; 95% CI -0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions., Conclusions: The CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group., Trial Registration Number: ISRCTN13517704., Competing Interests: Competing interests: GC is a member of the HTA Commissioning Board. A Price has a consultancy with Zimmer Biomet, outside the submitted work. MU has grants from NIHR, during the conduct of the study; grants from NIHR, Personal fees from NIHR, Personal fees from NICE, non financial support from Stryker PLC, grants from SERCO. SL has grants from NIHR Health Technology Assessment Programme during the conduct of the study and is a member of the following Boards: HTA Additional Capacity Funding Board 2010-2015, HTA Clinical Trials Board 2010-2015, HTA End of Life Care and Add on Studies 2015-2015, HTA Funding Boards Policy Group (Formally CSG) 2010–2015, HTA MNCH Methods Group 2013–2015, HTA Post-board funding teleconference (PG members to attend) 2010–2015, HTA Primary Care Themed Call board 2013–2014, HTA Prioritisation Group 2014–2015, NIHR CTU Standing Advisory Committee 2012–2016., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Background: Over 100,000 primary knee arthroplasty operations are undertaken annually in the UK. Around 15-30% of patients do not report a good outcome. Better rehabilitation strategies may improve patient-reported outcomes., Objectives: To compare the outcomes from a traditional outpatient physiotherapy model with those from a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty., Design: An individually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study., Setting: The trial took place in 14 NHS physiotherapy departments., Participants: People identified as being at high risk of a poor outcome after knee arthroplasty., Interventions: A multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy., Main Outcome Measures: The primary outcome was the Late Life Function and Disability Instrument at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function); Knee injury and Osteoarthritis Outcome Score; Quality of Life subscale; Physical Activity Scale for the Elderly; EuroQol-5 Dimensions, five-level version; and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance. Data on the use of health-care services, time off work and informal care were collected using participant diaries., Results: In total, 621 participants were randomised. A total of 309 participants were assigned to the COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme, receiving a median of five treatment sessions (interquartile range 4-7 sessions). A total of 312 participants were assigned to usual care, receiving a median of four sessions (interquartile range 2-6 sessions). The primary outcome, Late Life Function and Disability Instrument function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual-care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference 0.49 points, 95% confidence interval -0.89 to 1.88 points; p  = 0.48). There were no statistically significant differences between the groups in any of the patient-reported or physical secondary outcome measures at 6 or 12 months post randomisation. The health economic analysis found that the CORKA intervention was cheaper to provide than usual care (£66 less per participant). Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant). Adopting a societal perspective, CORKA had a 75% probability of being cost-effective at a threshold of £30,000 per quality-adjusted life-year. Adopting the narrower health and social care perspective, CORKA had a 43% probability of being cost-effective at the same threshold., Limitations: The interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded., Conclusions: This randomised controlled trial found no important differences in outcomes when post-arthroplasty rehabilitation was delivered using a home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model. However, the health economic evaluation found that when adopting a societal perspective, the CORKA home-based intervention was cost-saving and more effective than, and thus dominant over, usual care, owing to reduced time away from paid employment for this group. Further research could look at identifying the risk of poor outcome and further evaluation of a cost-effective treatment, including the workforce model to deliver it., Trial Registration: Current Controlled Trials ISRCTN13517704., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 65. See the NIHR Journals Library website for further project information.

Background: The number of knee arthroplasties performed each year is steadily increasing. Although the outcome is generally favourable, up to 15 % fail to achieve a satisfactory clinical outcome which may indicate that the existing model of rehabilitation after surgery may not be the most efficacious. Given the increasing number of knee arthroplasties, the relative limited physiotherapy resources available and the increasing age and frailty of patients receiving arthroplasty surgery, it is important that we concentrate our rehabilitation resources on those patients who most need help to achieve a good outcome. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of a community-based multidisciplinary rehabilitation intervention in comparison to usual care., Methods/design: The trial is designed as a prospective, single-blind, two-arm randomised controlled trial (RCT). A bespoke algorithm to predict which patients are at risk of poor outcome will be developed to screen patients for inclusion into a RCT using existing datasets. Six hundred and twenty patients undergoing knee arthroplasty, and assessed as being at risk of poor outcome using this algorithm, will be recruited and randomly allocated to one of two rehabilitation strategies: usual care or an individually tailored community-based rehabilitation package. The primary outcome is the Late Life Function and Disability Instrument measured at 1 year after surgery. Secondary outcomes include the Oxford Knee Score, the Knee injury and Osteoarthritis Outcome Score quality of life subscale, the Physical Activity Scale for the Elderly, the EQ-5D-5L and physical function measured by three performance-based tests: figure of eight, sit to stand and single-leg stand. A nested qualitative study will explore patient experience and perceptions and a health economic analysis will assess whether a home-based multidisciplinary individually tailored rehabilitation package represents good value for money when compared to usual care., Discussion: There is lack of consensus about what constitutes the optimum package of rehabilitation after knee arthroplasty surgery. There is also a need to tailor rehabilitation to the needs of those predicted to do least well by focussing on interventions that target the elderly and frailer population receiving arthroplasty surgery., Trial Registration: ISRCTN 13517704 , registered on 12 February 2015.