Abstract
There is a lack of evidence as to the best way to deliver rehabilitation following TKA. Previous work has suggested that postoperative physiotherapy applied to all patients is not effective at improving one-year post-surgical outcomes. The aim of this study was to target physiotherapy to those at risk of poor outcome following TKA, and to determine if a therapist-led intervention offered superior results compared to a home-exercise based protocol in this ‘at risk’ group.
The Targeted Rehabilitation to Improve Outcomes (TRIO) study was a prospective randomised controlled trial run at 15-centres in the UK. Patients were identified as ‘potential poor outcome’ based on an Oxford Knee Score (OKS) classification at 6-weeks post-surgery and randomised to either therapist-led or home-exercise based protocols. Patients were reviewed by a physiotherapist and commenced 18-exercise sessions over 6-weeks. The therapist-led group undertook a progressive functional protocol (modified weekly in 1-1 contact sessions) in contrast to the static home-exercise based regime. Evaluation took place following rehabilitation intervention, then at 6-months and 1-year post-surgery. Primary outcome was comparative group OKS at 1-year. Secondary outcomes included, ‘worst’ and ‘average’ pain scores, OXS and EQ-5D, and satisfaction questionnaire. Health economic (cost-utility) analysis was undertaken from NHS perspective up to 1-year post-surgery. Incremental cost per Quality Adjusted Life Years (QALYs) were calculated from intervention costs, patient reported primary and secondary care usage, and EQ-5D data.
4264 patients were screened, 1296 were eligible, 334 patients were randomised, 8 were lost to follow-up, therapy compliance was >85%. Clinically meaningful improvement in OKS (between baseline and 1-year) was seen in both arms (p < 0 .001). Between group difference in 1-year OKS was 1.91 (95%CI, −0.17–3.99) points favouring the therapist-led arm (p=0.07). Incorporating all time point data, between group difference in OKS was 2.25 points (95%CI, 0.61–3.90, p=0.008). Small, non-significant reductions (< 5 %) in both worst and average pain scores were observed favouring the therapist-led group. Enhanced satisfaction with pain relief (OR 1.65, p < 0 .02), ability to perform daily functional tasks (OR 1.66, p < 0 .02), and perform heavy functional tasks (OR 1.6, p=0.04) was reported in the therapist-led group. There was a small non-significant difference of 0.02 points (95%CI −0.02–0.06) between groups in EQ-5D, resulting in a £12,125 cost per QALY of delivering the therapist led intervention with a 57% chance of being cost-effective at the standard UK policy threshold of £20,000 per QALY.
TRIO is the largest randomised trial of physiotherapy following TKA, and the first to target rehabilitation to patients at risk of poor outcomes. Both therapist-led and home-exercise based rehabilitation groups made clinically meaningful improvements in outcome by 1-year. We observed a modest difference in OKS in favour of therapist-led rehabilitation compared to the home-exercises which was not statistically significant. The relatively tight confidence intervals suggests that any difference which might exist is too small to be clinically relevant. Patient satisfaction with outcome was however higher in those that received greater physiotherapist contact. While cost per QALY estimates were below UK policy threshold, this result is uncertain and insufficient to make accept-decline recommendations.
