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Enrollment and data collection insufficient to continue study.
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The purpose of this study is to evaluate the use and efficacy of the Encore Foundation Knee System in a group of 200 patients for whom data has already been collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foundation Knee | Retrospective data collection on 510(k) approved device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foundation Knee | Device | Subjects with degenerative joint disease (DJD), osteoarthritis or rheumatoid arthritis who received a primary Foundation Knee replacement and is willing to participate in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| The use and efficacy of the Encore Foundation Knee System | 2 year |
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Inclusion Criteria:
Have knee joint disease related to one or more of the following
Skeletal maturity
Less than 70 on the Knee Society Score (rating score)
Sufficient bone stock, as judged by radiographs, to support primary knee implant
Sufficient collateral ligaments to support the device, as judged by physician during stability testing (varus/valgus and flexion/extension) and less than 45 degree varus/valgus deformity and/or 90 degree flexion contracture
Patient is likely to be available for evaluation for the duration of the study
Able and willing to sign the informed consent and follow study procedures
Patient is not pregnant
No infection present
No known materials sensitivity
Exclusion Criteria:
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Individuals who meet the indications for use of the Foundation Knee device AND who meet the inclusion/exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Omar Hussamy, M.D. | Hussamy Orthopedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hussamy Orthopedics | Vero Beach | Florida | 32960 | United States |
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| Label | URL |
|---|---|
| Sponsor Company home page | View source |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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