Effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement for osteoarthritis: study protocol for a randomised controlled trial.
Primary total knee replacement is a common operation that is performed to provide pain relief and restore functional ability. Inpatient physiotherapy is routinely provided after surgery to enhance recovery prior to hospital discharge. However, international variation exists in the provision of outpatient physiotherapy after hospital discharge. While evidence indicates that outpatient physiotherapy can improve short-term function, the longer term benefits are unknown. The aim of this randomised controlled trial is to evaluate the long-term clinical effectiveness and cost-effectiveness of a 6-week group-based outpatient physiotherapy intervention following knee replacement.



Two hundred and fifty-six 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 referred 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 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.



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 health care resource efficiency.



ISRCTN32087234 , registered on 11 February 2015.
Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Learning and Research Building (Level 1), Southmead Hospital, Bristol, BS10 5NB, UK. v.wylde@bristol.ac.uk.
Vikki
V
Wylde
School of Health Professions, University of Plymouth, Peninsula Allied Health Centre, Derriford Road, Plymouth, Devon, PL6 8BH, UK.
Neil
N
Artz
Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Learning and Research Building (Level 1), Southmead Hospital, Bristol, BS10 5NB, UK.|National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care West (CLAHRC West), University Hospitals Bristol NHS Foundation Trust, Upper Maudlin Street, Bristol, BS2 8HW, UK.
Elsa
E
Marques
Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Learning and Research Building (Level 1), Southmead Hospital, Bristol, BS10 5NB, UK.
Erik
E
Lenguerrand
Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Learning and Research Building (Level 1), Southmead Hospital, Bristol, BS10 5NB, UK.
Samantha
S
Dixon
Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Learning and Research Building (Level 1), Southmead Hospital, Bristol, BS10 5NB, UK.
Andrew D
AD
Beswick
Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Learning and Research Building (Level 1), Southmead Hospital, Bristol, BS10 5NB, UK.
Amanda
A
Burston
North Bristol NHS Trust, Brunel Building, Southmead Hospital, Bristol, BS10 5NB, UK.
James
J
Murray
Emersons Green Independent Treatment Centre, The Brooms, Emersons Green, Bristol, BS16 7FH, UK.
Tarique
T
Parwez
Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Learning and Research Building (Level 1), Southmead Hospital, Bristol, BS10 5NB, UK.
Ashley W
AW
Blom
Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Learning and Research Building (Level 1), Southmead Hospital, Bristol, BS10 5NB, UK.
Rachael
R
Gooberman-Hill
D000553:Ambulatory Care / Q000191:economics*; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects / Q000191:economics*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004739:England; D017048:Health Care Costs; D006801:Humans; D007719:Knee Joint / Q000503:physiopathology / Q000601:surgery*; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000191:economics* / Q000503:physiopathology / Q000601:surgery*; D017060:Patient Satisfaction; D026741:Physical Therapy Modalities / Q000009:adverse effects / Q000191:economics*; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D020127:Recovery of Function; D012107:Research Design; D013222:State Medicine / Q000191:economics; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
Economic evaluation; Function; Physiotherapy; Randomised controlled trial; Total knee replacement