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Suspended pending internal review/direction of the company's focus.
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This is a prospective multicenter study of the LPS-Flex Porous Femoral Components when used in primary total knee arthroplasty. The purpose of the study is to obtain short-, mid-, and long-term clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous Femoral components.
Survival and outcome data on the NexGen LPS-Flex Porous Femoral Components will be done by an analysis of standard scoring system, radiographs and adverse event records. Survivorship will be evaluated by monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated adverse device effects. Outcomes will be measured by comparing the overall pain and function performances (based on the Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters of study subjects receiving the LPS-Flex Porous Femoral Components.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - LPS Flex Pororus Femoral Components | Patients suffering from severe knee pain and disability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LPS Flex Porous Femoral Components | Device | Porous femoral components in total knee arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | Based on frequency of adverse events, serious adverse events, adverse device effects, serious adverse device effects and unanticipated adverse device effects or removal of the device summarized using a Kaplan-Meier method and presented with rates (as percentages) and confidence intervals. | 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Functional Performance | Measured by comparing the overall pain and function performances (based on Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters. | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Each investigator will screen from this patient populatin patients suffering from severe knee pain and disability who meet the inclusion/exclusion criteria for study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Kacy Arnold, RN, MBA | Zimmer Biomet | Study Director |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D003095 | Collagen Diseases |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |