Abstract
Objective To evaluate whether a progressive course of outpatient physiotherapy offers superior outcomes to a single physiotherapy review and home exercise based intervention when targeted at patients with a predicted poor outcome after total knee arthroplasty.
Design Parallel group randomised controlled trial.
Setting 13 secondary and tertiary care centres in the UK providing postoperative physiotherapy.
Participants 334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively. 163 were allocated to therapist led outpatient rehabilitation and 171 to a home exercise based protocol.
Interventions All participants were reviewed by a physiotherapist and commenced 18 sessions of rehabilitation over six weeks, either as therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist).
Main outcome measures Primary outcome was Oxford knee score at 52 weeks, with a 4 point difference between groups considered to be clinically meaningful. Secondary outcomes included additional patient reported outcome measures of pain and function at 14, 26, and 52 weeks post-surgery.
Results 334 patients were randomised. Eight were lost to follow-up. Intervention compliance was more than 85%. The between group difference in Oxford knee score at 52 weeks was 1.91 (95% confidence interval −0.18 to 3.99) points, favouring the outpatient rehabilitation arm (P=0.07). When all time point data were analysed, the between group difference in Oxford knee score was a non-clinically meaningful 2.25 points (0.61 to 3.90, P=0.01). No between group differences were found for secondary outcomes of average pain (0.25 points, −0.78 to 0.28, P=0.36) or worst pain (0.22 points, −0.71 to 0.41, P=0.50) at 52 weeks or earlier time points, or of satisfaction with outcome (odds ratio 1.07, 95% confidence interval 0.71 to 1.62, P=0.75) or post-intervention function (4.64 seconds, 95% confidence interval −14.25 to 4.96, P=0.34).
Conclusions Outpatient therapist led rehabilitation was not superior to a single physiotherapist review and home exercise based regimen in patients at risk of poor outcomes after total knee arthroplasty. No clinically relevant differences were observed across primary or secondary outcome measures.
Trials registration Current Controlled Trials ISRCTN23357609 and ClinicalTrials.gov NCT01849445.
| Original language | English |
|---|---|
| Article number | m3576 |
| Pages (from-to) | 1-8 |
| Number of pages | 8 |
| Journal | BMJ |
| Volume | 371 |
| DOIs | |
| Publication status | Published - 13 Oct 2020 |
Bibliographical note
Funding: This study was funded by Arthritis Research UK (now Versus Arthritis), ref 20100, and sponsored by ACCORD (the University of Edinburgh and NHS Lothian). The funder had no role in study design, data collection, data analysis, data interpretation, writing of the article, or the decision to submit the paper for publication.Acknowledgments
We thank the study participants and the investigators, physiotherapists, and research teams for delivering the study at the participating centres; the Edinburgh Clinical Trials Unit for coordinating the project, in particular Chris Tuck, Elaine Kinsella, and Philip Rayson (trial management team), Valentina Assi (statistics), Ronnie Harkess (programming), and Lyndsey Milne (data management); and the support and advice at all study stages of the independent trial oversight and data monitoring committee: Alex MacGregor (University of East Anglia), Martin Lewis (Keele University), Michael Docherty (University of Nottingham), and Merfyn Williams (lay member).
TRIO investigators include: Caroline Austrie, the Royal Free Hospital, London; Kim Brown, Rehabilitation Centre, Queen Alexandria Hospital, Portsmouth; Matthew Carr, the Horder Centre, Crowborough; Ivan Brenkel, Victoria Hospital, Kirkcaldy; Tom Briggs, Doncaster Royal Infirmary, Doncaster; Katherine Dillow, Daren’t Valley Hospital, Dartford; Jamila Kassam, Royal London Hospital, London; Ben Lankester, Yeovil District Hospital, Yeovil; Emma McLoughlin, Rehabilitation Centre, Queen Alexandria Hospital, Portsmouth; Helen Samuel (Nee Sankey), the Tunbridge Wells Hospital, Pembury; Jason Seaton, Weston General Hospital, Weston Super Mare; Kate Weatherly, Conquest Hospital, St. Leonards-on-Sea.
Keywords
- GO TEST
- MOBILITY
- OSTEOARTHRITIS
- OXFORD HIP
- PROJECTIONS
- QUESTIONNAIRE
- REPLACEMENT
- REVISION
- SCORES
- UNITED-STATES