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Trial registered on ANZCTR
Registration number
ACTRN12611000284965
Ethics application status
Not yet submitted
Date submitted
16/03/2011
Date registered
17/03/2011
Date last updated
17/03/2011
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of the Genutrain knee brace in patients with knee osteoarthritis: a randomised controlled trial.
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Scientific title
The effect of the Genutrain knee brace on joint pain and activity limitation when compared with a generic neoprene knee brace in the treatment of knee osteoarthritis: a randomised controlled trial.
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Secondary ID [1]
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Nil
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Universal Trial Number (UTN)
U1111-1119-9625
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis
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Condition category
Condition code
Musculoskeletal
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0
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study will investigate the effectiveness of an off-the-shelf functional knee orthosis that provides compression and support to the knee joint. The knee orthosis is called the Genutrain knee brace and is fabricated by a German company called Bauerfeind. The knee orthosis will be worn by patients on a daily basis for a period of two months.
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Intervention code [1]
264221
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Treatment: Devices
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Comparator / control treatment
A control group will wear a standard (commercially available) neoprene knee orthosis on a daily basis for a period of two months.
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Control group
Active
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Outcomes
Primary outcome [1]
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Pain measured on a visual analogue scale.
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Assessment method [1]
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Timepoint [1]
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At baseline and 2 months after wearing the knee brace.
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Secondary outcome [1]
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Timed up-and-go test. The time it takes for the subject to stand from a chair, walk 3 meters, turn around, walk back to the chair and sit down.
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Assessment method [1]
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Timepoint [1]
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At baseline and 2 months after wearing the knee brace.
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Secondary outcome [2]
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Knee Osteoarthritis Scoring System (KOSS)
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Assessment method [2]
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Timepoint [2]
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At baseline and 2 months after wearing the knee brace.
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Eligibility
Key inclusion criteria
Aged 50-80 years.
Diagnosed by a specialist with symptomatic osteoarthritis affecting the knee(s) based on the ACR criteria.
Ambulant.
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Minimum age
50
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Significant valgus/varus malalignment of the knees (>10 degrees)
Other symptomatic musculoskeletal impairments affecting the lower limbs.
Inability to donn/doff a knee brace independently.
Leg size outside of the sizing guidelines for the knee brace.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by dice-rolling.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
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3121
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Recruitment postcode(s) [2]
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3125
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Recruitment postcode(s) [3]
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3002
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Recruitment postcode(s) [4]
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3130
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Melbourne Orthotics Pty Ltd
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Address [1]
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44 Highbury Road
Burwood
Victoria 3125
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Country [1]
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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MAS Medical Pty Ltd
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Address [2]
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44 Highbury Road
Burwood
Victoria 3125
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Country [2]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Melbourne Orthotics Pty Ltd
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Address
44 Highbury Road
Burwood
Victoria 3125
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Country
Australia
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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MAS Medical Pty Ltd
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Address [1]
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44 Highbury Road
Burwood
Victoria 3125
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Country [1]
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Professor Kim Bennell
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Address [1]
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Melbourne University
Department of Physiotherapy
200 Berkeley Street
Parkville
Victoria 3010
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Country [1]
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Ethics committee address [1]
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Ethics committee country [1]
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Date submitted for ethics approval [1]
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01/04/2011
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Approval date [1]
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Ethics approval number [1]
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Summary
Brief summary
This study aims to examine the effectiveness of the Genutrain knee brace in people with symptomatic osteoarthritis of the knee. The Genutrain knee brace will be compared with a standard generic (commerically available) neoprene knee brace and outcomes based on pain and activity will be assessed. It is hypothesised that the Genutrain knee brace will provide greater pain relief and allow improved movement of the knee joint when compared with a standard knee brace.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Aileen Ibuki
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Address
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44 Highbury Road
Burwood
Victoria 3125
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Country
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Australia
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Phone
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+61 1300 013 061
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Aileen Ibuki
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Address
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44 Highbury Road
Burwood
Victoria 3125
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Country
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Australia
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Phone
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+61 1300 013 061
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Fax
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Email
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[email protected]
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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
No additional documents have been identified.
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