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
43 participants
OBSERVATIONAL
2010-08-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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"In Office"
These subjects will come into the office to perform the consenting process, and complete all evaluations required at the only visit in the study.
cruciate-retaining Foundation Knee system
subjects who received the cruciate-retaining Foundation Knee system greater than or equal to 10 years ago and still maintain the original device in their knee.
"Telephone Arm"
These subjects will be consented over the phone and give a verbal consent to participate. They will complete all aspects of the study over the phone except for the knee society score evaluation and the x-ray.
cruciate-retaining Foundation Knee system
subjects who received the cruciate-retaining Foundation Knee system greater than or equal to 10 years ago and still maintain the original device in their knee.
Interventions
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cruciate-retaining Foundation Knee system
subjects who received the cruciate-retaining Foundation Knee system greater than or equal to 10 years ago and still maintain the original device in their knee.
Eligibility Criteria
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Inclusion Criteria
* Surgery must have been a primary knee replacement.
* Subject must have received only one primary knee replacement per hospitalization
* Subject must have had a primary diagnosis of osteoarthritis of the operative knee.
* Subject is able and willing to sign the informed consent document
Exclusion Criteria
* Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is a prisoner
ALL
Yes
Sponsors
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Encore Medical, L.P.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard J Friedman, M.D.
Role: PRINCIPAL_INVESTIGATOR
Charleston Orthopedic Association
Joseph A Longo III, M.D.
Role: PRINCIPAL_INVESTIGATOR
Locations
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Scottsdale, Arizona, United States
Charleston Orthopaedic Assoc.
Charleston, South Carolina, United States
Countries
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Other Identifiers
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PS-705
Identifier Type: -
Identifier Source: org_study_id