ANZCTR - Registration

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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

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

Condition category

Condition code

Musculoskeletal

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]

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]

Pain subscale on the Western Ontario and McMaster Universities (WOMAC) Scale (pain in the knee over the last 48 hours)

Timepoint [1]

6 weeks, 6 months and 12 months after randomisation

Primary outcome [2]

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]

6 weeks, 6 months and 12 months after randomisation

Secondary outcome [1]

Quality of life (SF-12 version 2)

Timepoint [1]

6 weeks, 6 months and 12 months after randomisation

Secondary outcome [2]

Arthritis severity and priority for surgery (Multi-attribute Arthritis Prioritisation Tool, MAPT)

Timepoint [2]

6 weeks, 6 months and 12 months after randomisation

Secondary outcome [3]

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]

6 weeks, 6 months and 12 months after randomisation

Secondary outcome [4]

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]

6 weeks, 6 months and 12 months after randomisation

Secondary outcome [5]

Use of analgesics over past 7 days (self-report survey)

Timepoint [5]

6 weeks, 6 months and 12 months after randomisation

Secondary outcome [6]

Walking speed on the 50 ft walk test

Timepoint [6]

6 weeks, 6 months and 12 months after randomisation

Secondary outcome [7]

Knee flexion and extension range of motion measured by an extendable goniometer

Timepoint [7]

6 weeks, 6 months and 12 months after randomisation

Secondary outcome [8]

Maximal isometric knee flexion and extension strength measured with a hand-held dynamometer

Timepoint [8]

6 months and 12 months after randomisation

Secondary outcome [9]

Lower limb power measured on the stair climbe test (ascending 10 stairs)

Timepoint [9]

6 weeks, 6 months and 12 months after randomisation

Secondary outcome [10]

Knee stability - the self-reported degree to which knee instability (partial giving way or full giving way) affects daily activities

Timepoint [10]

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?

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]

Charities/Societies/Foundations

Name [1]

HCF Health and Medical Research Foundation

Address [1]

GPO BOX 4242, Sydney, 2001

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

MBF Foundation

Address [2]

50 Bridge St, Sydney NSW 2000

Country [2]

Australia

Funding source category [3]

University

Name [3]

The University of Sydney

Address [3]

The University of Sydney
Camperdown
NSW 2006

Country [3]

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]

Other Collaborative groups

Name [1]

The MARKER (Maximum Recovery After Knee Replacement Surgery) Collaborative Group

Address [1]

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]

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

Address

Country

Phone

Fax

Contact person for public queries

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

Phone

+ 61 2 93519829

Fax

[email protected]

Contact person for scientific queries

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

Phone

+612 93519829

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Early rehabilitation after total knee replacement surgery: A multicenter, noninferiority, randomized clinical trial comparing a home exercise program with usual outpatient care.	2015	https://dx.doi.org/10.1002/acr.22457
Embase	Self-Reported Knee Instability before and after Total Knee Replacement Surgery.	2016	https://dx.doi.org/10.1002/acr.22692
Embase	Post-Acute Rehabilitation After Total Knee Replacement: A Multicenter Randomized Clinical Trial Comparing Long-Term Outcomes.	2017	https://dx.doi.org/10.1002/acr.23117

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically