RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs
NCT ID: NCT03554720
Last Updated: 2024-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2018-07-04
2024-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard implants
ATTUNE PS Knee
ATTUNE PS Knee
The ATTUNE PS Knee is the standard implants.
Enhanced-Fixation
ATTUNE S+ PS Knee
ATTUNE S+ PS Knee
The ATTUNE S+ PS Knee is the enhanced fixation.
Interventions
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ATTUNE PS Knee
The ATTUNE PS Knee is the standard implants.
ATTUNE S+ PS Knee
The ATTUNE S+ PS Knee is the enhanced fixation.
Eligibility Criteria
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Inclusion Criteria
* Between the ages of 21 and 80 inclusive
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent
Exclusion Criteria
* Medical condition precluding major surgery
21 Years
80 Years
ALL
Yes
Sponsors
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Orthopaedic Innovation Centre
OTHER
Dalhousie University
OTHER
London Health Sciences Centre
OTHER
Canadian Radiostereometric Analysis Network
OTHER
Responsible Party
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Principal Investigators
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Thomas Turgeon, MD MPH FRCSC
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Glen Richardson, MD MSc FRCSC
Role: PRINCIPAL_INVESTIGATOR
Dalhousie University
Douglas Naudie, MD FRCSC
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre
Locations
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Concordia Hospital
Winnipeg, Manitoba, Canada
London Health Sciences Centre
London, Ontario, Canada
Countries
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Other Identifiers
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HS21601
Identifier Type: -
Identifier Source: org_study_id
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