Objectives: To evaluate whether a progressive course of outpatient physiotherapy offers superior outcomes to a single physiotherapy review and home-exercise based intervention when targeted to patients at risk of poor outcome following total knee arthroplasty.
Study 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 defined as at risk of poor outcome following total knee arthroplasty were randomised. Patients were identified as ‘potential poor outcome’ based on an Oxford Knee Score (OKS) classification at 6-weeks post-surgery.
Interventions: All participants were reviewed by a physiotherapist and commenced 18-sessions of rehabilitation over 6-weeks, either outpatient physiotherapy (based on a progressive goal-orientated functional rehabilitation protocol, modified weekly in 1-1 contact sessions) or physiotherapy review followed by a home-exercise based regimen (without progressive input from a physiotherapist).
Main Outcomes: Primary outcome was comparative group Oxford Knee Score (OKS) at 52-weeks, with a 4-point difference accepted as 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. 8 were lost to follow-up. Intervention compliance was >85%. Between group difference in 52-week OKS was 1.91 (95%CI, -0.17 to 3.99) points favouring the outpatient physiotherapy arm (p=0.07). Incorporating all time point data, between group difference in OKS was 2.25 points (95%CI, 0.61 to 3.90, p=0.008), which was not clinically meaningful. There were no differences between groups in secondary outcomes of average pain, 0.25 points (95%CI, -0.78 to 0.28, p=0.36) or worst pain, 0.22 points (95%CI, -0.71 to 0.41, p=0.50) at 52-weeks, or at earlier timepoints. Satisfaction with outcome was not different between groups OR 1.07 (95%CI 0.71 to 1.62, p=0.75). Post-intervention function was not different between groups, 4.64 seconds (95%CI, -14.25 to 4.96, p=0.34).
Conclusions: Outpatient physiotherapy did not facilitate superior outcomes compared to a single physiotherapist review and home-based exercise regimen even when targeted to patients at risk of poor outcomes following total knee arthroplasty. No clinically relevant differences were observed across primary or secondary outcome measures. While targeting rehabilitation interventions to ‘at risk’ patients is a feasible delivery method, the content of the rehabilitation tested had minimal influence on patient outcomes. Policy and guideline makers may wish to consider the resource implications of outpatient therapy for this high-volume procedure.
Trials Registration: Current Controlled Trials (ISRCTN23357609) and ClinicalTrials.gov (NCT01849445).
|Publication status||Accepted/In press - 24 Aug 2020|