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Open Access Highly Accessed Study protocol

Maximum recovery after knee replacement – the MARKER study rationale and protocol

Chung-Wei Christine Lin1, Lyn March2, Jack Crosbie3, Ross Crawford4, Stephen Graves5, Justine Naylor6, Alison Harmer3, Stephen Jan1, Kim Bennell7, Ian Harris8, David Parker9, Helene Moffet10 and Marlene Fransen111*

Author Affiliations

1 The George Institute for International Health, The University of Sydney, PO Box M201, Missenden Rd, Sydney NSW 2050, Australia

2 Department of Rheumatology, Royal North Shore Hospital, St Leonards, NSW 2065, Australia

3 Discipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, PO Box 170, Lidcombe NSW 1825, Australia

4 Queensland University of Technology, 2 George St, Brisbane, QLD 4001, Australia

5 Discipline of Public Health, University of Adelaide, Mail Drop 511, SA 5005, Australia

6 Whitlam Orthopaedic Research Centre, Orthopaedic Department, Liverpool Hospital, Locked Bag 7103, Liverpool BC NSW 1871, Australia

7 Centre for Health, Exercise and Sports Medicine, School of Physiotherapy, University of Melbourne, 200 Berkeley Street, Melbourne VIC 3010, Australia

8 Director of Orthopaedics, Liverpool Hospital, Locked Bag 7103, Liverpool BC NSW 1871, Australia

9 Sydney Orthopaedic Research Institute, Level 1, The Gallery, 445 Victoria Ave, Chatswood NSW 2067, Australia

10 Department of Rehabilitation, Faculty of Medicine, Laval University Pavillon Ferdinand-Vandry, Room 4463, Québec, QC G1M 2S8, Canada

11 Current address: Clinical and Rehabilitation Sciences Research Group, Faculty of Health Sciences, The University of Sydney, PO Box 170, Lidcombe NSW 1825, Australia

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BMC Musculoskeletal Disorders 2009, 10:69  doi:10.1186/1471-2474-10-69

Published: 17 June 2009

Abstract

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/Design

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.

Discussion

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.

Trial Registration

ACTRN12609000054213