Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000476235
Ethics application status
Approved
Date submitted
9/06/2009
Date registered
17/06/2009
Date last updated
19/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trialling Rehabilitation After Knee Replacement
Scientific title
The effect of one-to-one physiotherapy, class-based physiotherapy and monitored home program on patient-centred and physical outcomes following total knee replacement
Secondary ID [1] 263070 0
nil
Universal Trial Number (UTN)
Trial acronym
TRAKeR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total knee replacment 4794 0
Condition category
Condition code
Physical Medicine / Rehabilitation 237138 237138 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rehabilitation commences 2 weeks after surgery. (a)One-to-one physiotherapy: 12 30-minute sessions across 8 weeks, patients also performs 45-minute exercise program twice a week. Exercises target range of motion, strength, mobility and balance.(b)Class-based physiotherapy: 12 45-minute sessions across 8 weeks, patients also perform a 45-minute exercise program at home twice a week. Exercises target range of motion, strength, mobility and balance.
Intervention code [1] 4567 0
Rehabilitation
Comparator / control treatment
Rehabilitation commences 2 weeks after surgery. Monitored home program: Two 30-minute sessions of physiotherapy and one follow-up phone call across 8 weeks, patients perform 45-minute exercise program 4 times a week. Exercises target range of motion, strength, mobility and balance.
Control group
Active

Outcomes
Primary outcome [1] 237958 0
Western Ontario and McMaster University (WOMAC) Osteroarthritis Index (pain and function scores)
Timepoint [1] 237958 0
Pre-operative, 2 weeks, 10 weeks, 26 weeks and 52 weeks post total knee replacement
Primary outcome [2] 279814 0
Oxford knee score
Timepoint [2] 279814 0
PRe-operative, 10,26 and 52 weeks post total knee replacement.
Secondary outcome [1] 242056 0
Stair ascension power. Power will be calculated from measurement of time to ascend 10 steps (height 15cm each step). Patient is permitted to use walking aid and/or rail for safety.
Timepoint [1] 242056 0
2 weeks, 10 weeks, 26 weeks and 52 weeks post total knee replacement
Secondary outcome [2] 242057 0
Knee range of motion. This will be assessed by a photo taken of the patient's leg in supine, with skin markers placed on the lateral malleolus and greater trochanter, with the knee in maximum flexion and extension. A goiniometer will be used to measure the knee position in the photo using the markers as reference points.
Timepoint [2] 242057 0
Pre-operative, 2 weeks, 10 weeks, 26 weeks and 52 weeks post total knee replacement
Secondary outcome [3] 242058 0
Medical Outcomes Study Short Form (SF-12v2)
Timepoint [3] 242058 0
Pre-operative, 2 weeks, 10 weeks, 26 weeks and 52 weeks post total knee replacement
Secondary outcome [4] 242059 0
Global satisfaction with allocated program, measured using a self-administered questionnaire.
Timepoint [4] 242059 0
10 weeks post total knee replacement
Secondary outcome [5] 242060 0
Global satisfaction with recovery, measured using a self-administered questionnaire.
Timepoint [5] 242060 0
52 weeks post total knee replacement
Secondary outcome [6] 242061 0
Leisure time physical activity, measured using a self-administered questionnaire.
Timepoint [6] 242061 0
52 weeks post total knee replacement

Eligibility
Key inclusion criteria
Primary total knee replacement
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major co-morbidity precluding aerobic exercise at 50-60% maximum heart rate, history of dementia, history of stroke, multiple sclerosis or other neurological conditions causing physical
disability, not able to speak English, Arabic or Spanish, persistent post-operative confusion, deep wound infection, knee ligament instability, weight bearing restrictions on operated limb which limits participation of exercise program

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)
Subjects are recruited when they attend a pre-operative education session. Patients are screened by a research officer, and eligible patients are given a subject information sheet and consent form as approved by the Sydney South West Area Health Service human Research Ethics Committee. Consenting patients then underwent initial assessment. Following surgery, patients are assessed by a blinded assessor. Eligible subjects are then allocated into one of the three treatment groups by therapy staff (who are not blinded) by means of consecutively numbered concealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomised number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Intention to treat analysis employed
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1780 0
2170
Recruitment postcode(s) [2] 1781 0
2176

Funding & Sponsors
Funding source category [1] 5071 0
Other
Name [1] 5071 0
Fairfield Hospital Research Grant
Country [1] 5071 0
Australia
Funding source category [2] 5072 0
Other
Name [2] 5072 0
Whitlam Joint Replacement Centre
Country [2] 5072 0
Australia
Primary sponsor type
Hospital
Name
Fairfield Hospital
Address
Fairfield Hospital,
Cnr Polding St and Prairievale Rd Prairiewood NSW 2176
Country
Australia
Secondary sponsor category [1] 4580 0
None
Name [1] 4580 0
Address [1] 4580 0
Country [1] 4580 0
Other collaborator category [1] 701 0
University
Name [1] 701 0
University of NSW
Address [1] 701 0
The University of New South Wales
South Western Sydney Clinical School, Faculty of Medicine
Liverpool Health Service
Crn Elizabeth & Goulburn Streets
Liverpool NSW 2170
Country [1] 701 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239174 0
Sydney South West Area Health Service Human Research Ethics Committee (SSWAHS HREA)
Ethics committee address [1] 239174 0
Liverpool Hospital,
Elizabeth Dr
Liverpool NSW 2170
Ethics committee country [1] 239174 0
Australia
Date submitted for ethics approval [1] 239174 0
Approval date [1] 239174 0
Ethics approval number [1] 239174 0

Summary
Brief summary
The purpose of this study is to evaluate the effectiveness of class-based physiotherapy and one-to-one physiotherapy , compared to a monitored home program after total knee replacement surgery. The study hypothesis is that one-to-one physiotherapy will be superior compared to class-based physiotherapy or a monitored home program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29611 0
Address 29611 0
Country 29611 0
Phone 29611 0
Fax 29611 0
Email 29611 0
Contact person for public queries
Name 12858 0
Victoria Ko
Address 12858 0
Orthopaedic Department
Liverpool Hospital
Elizabeth Dr
Liverpool NSW 2170
Country 12858 0
Australia
Phone 12858 0
+61 2 9828 3887
Fax 12858 0
+61 2 9828 3884
Email 12858 0
Victoria.Ko@sswahs.nsw.gov.au
Contact person for scientific queries
Name 3786 0
Victoria Ko
Address 3786 0
Orthopaedic Department
Liverpool Hospital
Elizabeth Dr
Liverpool NSW 2170
Country 3786 0
Australia
Phone 3786 0
+61 2 9828 3887
Fax 3786 0
+61 2 9828 3884
Email 3786 0
Victoria.Ko@sswahs.nsw.gov.au

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
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