Methods/Design256 patients waiting for knee replacement because of osteoarthritis will be recruited from two orthopaedic centres. Participants randomised to the usual care group (n=128) will be given a booklet about exercise and referral for physiotherapy if deemed appropriate by the clinical care team. The intervention group (n=128) will receive the same usual care and additionally be invited to attend a group-based outpatient physiotherapy class starting at 6 weeks after surgery. The 1-hour class will be run on a weekly basis over 6 weeks and will involve task-orientated and individualised exercises.
The primary outcome will be the Lower Extremity Functional Scale at 12 months post-operative. Secondary outcomes include: quality of life, knee pain and function, depression, anxiety and satisfaction. Data collection will be by questionnaire prior to surgery and 3, 6 and 12 months after surgery and will include a resource use questionnaire to enable a trial-based economic evaluation. Trial participation and satisfaction with the classes will be evaluated through structured telephone interviews. The primary statistical and economic analyses will be conducted on an intention-to-treat basis with and without imputation of missing data. The primary economic result will estimate the incremental cost per quality adjusted life year gained from this intervention from a National Health Services (NHS) and personal social services perspective.
Discussion This research aims to benefit patients and the NHS by providing evidence on the long-term effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement. If the intervention is found to be effective and cost-effective, implementation into clinical practice could lead to improvement in patients’ outcomes and improved healthcare resource efficiency.
- Centre for Surgical Research
- Total knee replacement
- randomised controlled trial
- economic evaluation