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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.
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.
Secondary ID [1] 253551 0
Nil
Universal Trial Number (UTN)
U1111-1119-9625
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 261109 0
Condition category
Condition code
Musculoskeletal 259527 259527 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 264221 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 262336 0
Pain measured on a visual analogue scale.
Timepoint [1] 262336 0
At baseline and 2 months after wearing the knee brace.
Secondary outcome [1] 273561 0
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.
Timepoint [1] 273561 0
At baseline and 2 months after wearing the knee brace.
Secondary outcome [2] 273562 0
Knee Osteoarthritis Scoring System (KOSS)
Timepoint [2] 273562 0
At baseline and 2 months after wearing the knee brace.

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.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by dice-rolling.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3860 0
3121
Recruitment postcode(s) [2] 3861 0
3125
Recruitment postcode(s) [3] 3862 0
3002
Recruitment postcode(s) [4] 3863 0
3130

Funding & Sponsors
Funding source category [1] 264668 0
Self funded/Unfunded
Name [1] 264668 0
Melbourne Orthotics Pty Ltd
Country [1] 264668 0
Australia
Funding source category [2] 264669 0
Commercial sector/Industry
Name [2] 264669 0
MAS Medical Pty Ltd
Country [2] 264669 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Melbourne Orthotics Pty Ltd
Address
44 Highbury Road
Burwood
Victoria 3125
Country
Australia
Secondary sponsor category [1] 263805 0
Commercial sector/Industry
Name [1] 263805 0
MAS Medical Pty Ltd
Address [1] 263805 0
44 Highbury Road
Burwood
Victoria 3125
Country [1] 263805 0
Australia
Other collaborator category [1] 251874 0
Individual
Name [1] 251874 0
Professor Kim Bennell
Address [1] 251874 0
Melbourne University
Department of Physiotherapy
200 Berkeley Street
Parkville
Victoria 3010
Country [1] 251874 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266667 0
Ethics committee address [1] 266667 0
Ethics committee country [1] 266667 0
Date submitted for ethics approval [1] 266667 0
01/04/2011
Approval date [1] 266667 0
Ethics approval number [1] 266667 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32176 0
Address 32176 0
Country 32176 0
Phone 32176 0
Fax 32176 0
Email 32176 0
Contact person for public queries
Name 15423 0
Aileen Ibuki
Address 15423 0
44 Highbury Road
Burwood
Victoria 3125
Country 15423 0
Australia
Phone 15423 0
+61 1300 013 061
Fax 15423 0
Email 15423 0
aibuki@melborthotics.com
Contact person for scientific queries
Name 6351 0
Aileen Ibuki
Address 6351 0
44 Highbury Road
Burwood
Victoria 3125
Country 6351 0
Australia
Phone 6351 0
+61 1300 013 061
Fax 6351 0
Email 6351 0
aibuki@melborthotics.com

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.