Abstract
BackgroundThere is little scientific evidence to support the usual practice of providing outpatient rehabilitation to patients undergoing total knee replacement surgery (TKR) immediately after discharge from the orthopaedic ward. It is hypothesised that the lack of clinical benefit is due to the low exercise intensity tolerated at this time, with patients still recovering from the effects of major orthopaedic surgery. The aim of the proposed clinical trial is to investigate the clinical and cost effectiveness of a novel rehabilitation strategy, consisting of an initial home exercise programme followed, approximately six weeks later, by higher intensity outpatient exercise classes.Methods/DesignIn this multicentre randomised controlled trial, 600 patients undergoing primary TKR will be recruited at the orthopaedic pre-admission clinic of 10 large public and private hospitals in Australia. There will be no change to the medical or rehabilitative care usually provided while the participant is admitted to the orthopaedic ward. After TKR, but prior to discharge from the orthopaedic ward, participants will be randomised to either the novel rehabilitation strategy or usual rehabilitative care as provided by the hospital or recommended by the orthopaedic surgeon. Outcomes assessments will be conducted at baseline (pre-admission clinic) and at 6 weeks, 6 months and 12 months following randomisation. The primary outcomes will be self-reported knee pain and physical function. Secondary outcomes include quality of life and objective measures of physical performance. Health economic data (health sector and community service utilisation, loss of productivity) will be recorded prospectively by participants in a patient diary. This patient cohort will also be followed-up annually for five years for knee pain, physical function and the need or actual incidence of further joint replacement surgery.DiscussionThe results of this pragmatic clinical trial can be directly implemented into clinical practice. If beneficial, the novel rehabilitation strategy of utilising outpatient exercise classes during a later rehabilitation phase would provide a feasible and potentially cost-effective intervention to optimise the physical well-being of the large number of people undergoing TKR.Trial RegistrationACTRN12609000054213
Highlights
There is little scientific evidence to support the usual practice of providing outpatient rehabilitation to patients undergoing total knee replacement surgery (TKR) immediately after discharge from the orthopaedic ward
In Australia, the total number of TKR operations performed has increased by 150% in the past decade [1]
The mean age of patients undergoing TKR in Australia is 70 years, the proportion of patients aged less than 65 years at the time of surgery has been increasing over the years reaching 32% in 2007 [1]
Summary
The primary aim of the proposed pragmatic randomised controlled trial is to compare the effectiveness and costeffectiveness of a novel rehabilitation strategy, consisting of an initial home exercise programme followed by higher intensity outpatient exercise classes, to usual rehabilitative care in people undergoing primary TKR for OA. The costs of presenteeism will be estimated by the number of days worked weighted by the rate of presenteeism multiplied by the average wage rate for the relevant employment category. The costs of absenteeism will be estimated by the number of days absent from work multiplied by the average wage rate for the relevant employment category. The novel rehabilitation strategy could optimise outcomes in people after TKR and allow substantial cost savings to both the health sector and more widely across the community when compared to the usual, resource-intensive one to one outpatient intervention. The oneyear follow-up of all study participants should be completed by the end of 2011
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