Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000054213
Ethics application status
Approved
Date submitted
15/12/2008
Date registered
23/01/2009
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness and cost-effectiveness of a novel rehabilitation strategy in people undergoing primary total knee replacement surgery. The MARKER (Maximum Recovery After Knee Replacement Surgery) Study.
Scientific title
Effectiveness and cost-effectiveness of a novel rehabilitation strategy in people undergoing primary total knee replacement surgery. The MARKER (Maximum Recovery After Knee Replacement Surgery) Study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary total knee replacement surgery for osteoarthritis 4131 0
Condition category
Condition code
Musculoskeletal 4329 4329 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Novel rehabilitation strategy, consisting of rehabilitation provided in 2 stages.

Stage 1: Initial home exercise programme (usually Week 1 to 6 after hospital discharge). The exercises will focus on maintaining and improving active knee flexion and extension range of motion. Participants will perform 5 to 10 times of 3 to 5 exercises 3 times per day. Participants’ progress, including adherence to the home exercise programme, walking ability and knee symptoms will be monitored weekly by a research physiotherapist, with clinic visits in the first one or two weeks and by telephone calls thereafter.

Stage 2: Outpatient exercise classes (usually Week 6 to 14 after hospital discharge)
About four weeks after total knee replacement surgery, a research physiotherapist will commence screening during the weekly telephone calls to assess eligibility to commence the classes: (i) surgical wound healed, (ii) full weight-bearing tolerated on the operated limb, (iii) ambulating independently outdoors for more than 50 m, and (iv) not requiring daily opioid-based analgesics for knee pain.
The exercise classes will be circuit-based and supervised by a physiotherapist. The one hour classes will be conducted twice a week for eight weeks. Each class will consist of a warm up and cool down component, progressive functional and strengthening exercises, and a 20-minute monitored aerobic exercise session on stationary bicycles.
At the beginning of each exercise class, knee pain, range of motion and swelling will be evaluated to allow appropriate exercise progression. Class size will be restricted to a maximum of six participants. Participants will be required to do at least one additional intensive exercise session per week at home, consisting of 30 minutes of walking outdoors or stationary bicycle. In addition, one education class will be provided to participants, focusing on the rationale for increasing lower limb muscle strength and beneficial lifestyle behaviours appropriate after total knee replacement.
Intervention code [1] 3842 0
Rehabilitation
Comparator / control treatment
Usual care after discharge from the acute orthopaedic ward. This is could be inpatient or outpatient rehabilitation, or no treatment, according to the recommendation of the orthopaedic surgeon or to the usual practice at the recruitment centre.
Control group
Active

Outcomes
Primary outcome [1] 5214 0
Pain subscale on the Western Ontario and McMaster Universities (WOMAC) Scale (pain in the knee over the last 48 hours)
Timepoint [1] 5214 0
6 weeks, 6 months and 12 months after randomisation
Primary outcome [2] 5215 0
Physical function subscale on the Western Ontario and McMaster Universities (WOMAC) Scale (difficulties in physical activities in the knee over the last 48 hours)
Timepoint [2] 5215 0
6 weeks, 6 months and 12 months after randomisation
Secondary outcome [1] 8774 0
Quality of life (SF-12 version 2)
Timepoint [1] 8774 0
6 weeks, 6 months and 12 months after randomisation
Secondary outcome [2] 8775 0
Arthritis severity and priority for surgery (Multi-attribute Arthritis Prioritisation Tool, MAPT)
Timepoint [2] 8775 0
6 weeks, 6 months and 12 months after randomisation
Secondary outcome [3] 8776 0
Participation in leisure time physical activity (measured by the self-reported frequency and total duration over the past week of walking continuously, moderate physical activities and vigorous physical activities)
Timepoint [3] 8776 0
6 weeks, 6 months and 12 months after randomisation
Secondary outcome [4] 8777 0
Fatigue ('how much of a problem has fatigue or tiredness been for you in the last week?'. Responses will be required on a 100-mm visual analogue scale, ranging from 'fatigue is no problem' to 'fatigue is a major problem')
Timepoint [4] 8777 0
6 weeks, 6 months and 12 months after randomisation
Secondary outcome [5] 8778 0
Use of analgesics over past 7 days (self-report survey)
Timepoint [5] 8778 0
6 weeks, 6 months and 12 months after randomisation
Secondary outcome [6] 8779 0
Walking speed on the 50 ft walk test
Timepoint [6] 8779 0
6 weeks, 6 months and 12 months after randomisation
Secondary outcome [7] 8780 0
Knee flexion and extension range of motion measured by an extendable goniometer
Timepoint [7] 8780 0
6 weeks, 6 months and 12 months after randomisation
Secondary outcome [8] 8781 0
Maximal isometric knee flexion and extension strength measured with a hand-held dynamometer
Timepoint [8] 8781 0
6 months and 12 months after randomisation
Secondary outcome [9] 8782 0
Lower limb power measured on the stair climbe test (ascending 10 stairs)
Timepoint [9] 8782 0
6 weeks, 6 months and 12 months after randomisation
Secondary outcome [10] 8934 0
Knee stability - the self-reported degree to which knee instability (partial giving way or full giving way) affects daily activities
Timepoint [10] 8934 0
6 weeks, 6 months and 12 months after randomisation

Eligibility
Key inclusion criteria
undergoing unilateral or bilateral primary total knee replacement surgery, able to provide informed consent, able to be discharged home from the orthopaedic ward
Minimum age
45 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) previous unicompartmental replacement or tibial osteotomy on the same knee, (ii) previous lower limb joint replacement surgery within the last six months, (iii) further lower limb joint replacement surgery anticipated within the next 12 months, (iv) major co-morbidity precluding aerobic exercise at 50-60% maximum heart rate, (v) rheumatoid arthritis, (vi) major neurological conditions, or (vii) inability to return to one of the participating sites for outpatient exercise classes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4293 0
Charities/Societies/Foundations
Name [1] 4293 0
HCF Health and Medical Research Foundation
Country [1] 4293 0
Australia
Funding source category [2] 4294 0
Charities/Societies/Foundations
Name [2] 4294 0
MBF Foundation
Country [2] 4294 0
Australia
Funding source category [3] 4295 0
University
Name [3] 4295 0
The University of Sydney
Country [3] 4295 0
Australia
Primary sponsor type
Individual
Name
Dr Marlene Fransen
Address
Clinical and Rehabilitation Sciences Research Group, Faculty of Health Sciences, University of Sydney, PO Box 170, Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 3866 0
Other Collaborative groups
Name [1] 3866 0
The MARKER (Maximum Recovery After Knee Replacement Surgery) Collaborative Group
Address [1] 3866 0
C/O Associate Professor Marlene Fransen,
Clinical and Rehabilitation Sciences Research Group, Faculty of Health Sciences, University of Sydney, PO Box 170, Lidcombe NSW 1825
Country [1] 3866 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
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 demonstrated lack of 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 this study is to investigate the effectiveness of a novel rehabilitation strategy, consisting of an initial home exercise programme followed, about six weeks later, by outpatient exercise classes. It is hypothesised that the novel rehabilitation strategy will be more beneficial than the usual practice of providing outpatient rehabilitation immediately following discharge from the orthopaedic ward.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35040 0
Address 35040 0
Country 35040 0
Phone 35040 0
Fax 35040 0
Email 35040 0
Contact person for public queries
Name 12387 0
Dr Marlene Fransen
Address 12387 0
Clinical and Rehabilitation Sciences Research Group, Faculty of Health Sciences, University of Sydney, PO Box 170, Lidcombe NSW 1825
Country 12387 0
Australia
Phone 12387 0
+ 61 2 93519829
Fax 12387 0
Email 12387 0
[email protected]
Contact person for scientific queries
Name 3315 0
Dr Marlene Fransen
Address 3315 0
Clinical and Rehabilitation Sciences Research Group, Faculty of Health Sciences, University of Sydney, PO Box 170, Lidcombe NSW 1825
Country 3315 0
Australia
Phone 3315 0
+612 93519829
Fax 3315 0
Email 3315 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEarly rehabilitation after total knee replacement surgery: A multicenter, noninferiority, randomized clinical trial comparing a home exercise program with usual outpatient care.2015https://dx.doi.org/10.1002/acr.22457
EmbaseSelf-Reported Knee Instability before and after Total Knee Replacement Surgery.2016https://dx.doi.org/10.1002/acr.22692
EmbasePost-Acute Rehabilitation After Total Knee Replacement: A Multicenter Randomized Clinical Trial Comparing Long-Term Outcomes.2017https://dx.doi.org/10.1002/acr.23117
N.B. These documents automatically identified may not have been verified by the study sponsor.