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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02157220
Registration number
NCT02157220
Ethics application status
Date submitted
30/05/2014
Date registered
5/06/2014
Date last updated
5/06/2014
Titles & IDs
Public title
Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements
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Scientific title
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Secondary ID [1]
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HC12098
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Universal Trial Number (UTN)
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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:
Osteoarthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Randomised group 1 - This study is looking at a group of patients with knee osteoarthritis or other pathology requiring total knee arthroplasty. This group of patients were randomised to receive either a mobile bearing prosthesis or a fixed bearing prosthesis.
Experimental: Randomised group 2 - This study is looking at a group of patients with knee osteoarthritis or other pathology requiring total knee arthroplasty. This group of patients were randomised to receive either a mobile bearing prosthesis or a fixed bearing prosthesis.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Visual pain analogue score
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Assessment method [1]
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Participants asked to rate their level of pain on a scale
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Timepoint [1]
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6 weeks
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Primary outcome [2]
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Range of motion
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Assessment method [2]
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The range of motion of the joint was assessed in both flexion and extension
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Timepoint [2]
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6 weeks
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Primary outcome [3]
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Activities of Daily Living
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Assessment method [3]
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Questionnaire looking at how the intervention impacts of activities of daily living
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Timepoint [3]
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6 weeks
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Primary outcome [4]
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X-ray analysis of joint alignment
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Assessment method [4]
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Using X-rays, the knee was assessed for mechanical and anatomical alignment
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Timepoint [4]
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5-7 year
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Primary outcome [5]
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Visual pain analogue score
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Assessment method [5]
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Timepoint [5]
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6 months
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Primary outcome [6]
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visual pain analogue score
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Assessment method [6]
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Timepoint [6]
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12 months
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Primary outcome [7]
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visual analogue pain score
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Assessment method [7]
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Timepoint [7]
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5-7 years
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Primary outcome [8]
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range of motion
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Assessment method [8]
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Timepoint [8]
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6 months
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Primary outcome [9]
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range of motion
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Assessment method [9]
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Timepoint [9]
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1 year
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Primary outcome [10]
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range of motion
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Assessment method [10]
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Timepoint [10]
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5-7 years
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Primary outcome [11]
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activities of daily living
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Assessment method [11]
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Timepoint [11]
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6 months
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Primary outcome [12]
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activities of daily living
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Assessment method [12]
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Timepoint [12]
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1 year
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Primary outcome [13]
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activities of daily living
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Assessment method [13]
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Timepoint [13]
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5-7 years
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Eligibility
Key inclusion criteria
* patients presenting to a single orthopaedic surgeon with knee pathology, who were suitable candidates for total knee arthroplasty
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Minimum age
No limit
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Maximum age
No limit
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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
* refusal to participate
* other simultaneous surgery
* post traumatic osteoarthritis
* prior open knee surgery
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2005
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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
1/05/2014
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Sample size
Target
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Accrual to date
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Final
77
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Dr Dean Pepper, orthopaedic surgeon private rooms - Port Macquarie
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Recruitment postcode(s) [1]
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2444 - Port Macquarie
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of New South Wales
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a randomised control trial comparing two different prosthetic designs used in total knee arthroplasty. Participants were randomised to receive either of the two prostheses and then were followed up of a period of 7 years, looking at pain, range of motion and impact on quality of life. The literature and joint registry of Australia shows that one of the prosthesis may be inferior to the other. Our research team hypothesised that this was not the case and that previous elicited differences were related to other factors.
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Trial website
https://clinicaltrials.gov/study/NCT02157220
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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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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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 scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02157220
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