NCT01274546
Completed
Not Applicable
A Long-term, Multicenter Follow Up Study of the Cruciate-retaining Foundation Knee System
ConditionsTotal Knee Replacement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Knee Replacement
- Sponsor
- Encore Medical, L.P.
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Survivorship of the Device
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the cruciate-retaining Foundation Knee system during or prior to the year 2000.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must have received a cruciate-retaining Foundation Knee system during or prior to the year
- •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 must not have had any previous knee implants (unicondylar or total joint replacements)
- •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
Outcomes
Primary Outcomes
Survivorship of the Device
Time Frame: Single visit
The subject meets the inclusion/exclusion of the study and has a Foundation Knee that has survived without revision to date.
Secondary Outcomes
- WOMAC Osteoarthritis Index(Single visit)
- Knee Society Score Evaluation(Single visit)
- Short Form - 36(Single Visit)
- Oxford Knee Score Assessment(Single visit)
- Range of Motion(Single visit)
- Radiographic failure(Single visit)
Study Sites (1)
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