Maximum recovery after knee replacement--the MARKER study rationale and protocol.
BACKGROUND
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. 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
In 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.


CONCLUSIONS
The 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.


BACKGROUND
ACTRN12609000054213.
Lin
Chung-Wei Christine
CW
The George Institute for International Health, The University of Sydney, Sydney, NSW 2050, Australia. clin@george.org.au
March
Lyn
L
Crosbie
Jack
J
Crawford
Ross
R
Graves
Stephen
S
Naylor
Justine
J
Harmer
Alison
A
Jan
Stephen
S
Bennell
Kim
K
Harris
Ian
I
Parker
David
D
Moffet
Helene
H
Fransen
Marlene
M
D000203:Activities of Daily Living; D000368:Aged; D000553:Ambulatory Care / Q000379:methods* / Q000706:statistics & numerical data; D019645:Arthroplasty, Replacement, Knee / Q000191:economics / Q000534:rehabilitation*; D001315:Australia; D002985:Clinical Protocols / Q000592:standards; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D005081:Exercise Therapy / Q000191:economics / Q000379:methods* / Q000706:statistics & numerical data; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data; D006701:Home Nursing / Q000191:economics / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D051346:Mobility Limitation; D017063:Outcome Assessment, Health Care / Q000379:methods*; D020127:Recovery of Function / Q000502:physiology; D013997:Time Factors; D016896:Treatment Outcome