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The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).
The objective of this study is to demonstrate statistically significant improvements in the original Knee Society Clinical Score (KSCS) from baseline to 1 and 2 years in subjects using the LEGION™ Hinge Knee System. The focus of the 1 and 2 year analyses will be on safety and efficacy. The 5 year analysis will focus on survivorship and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEGION Hinge Knee System | This group will be receiving the LEGION Hinge device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEGION Hinge Knee System | Device | All enrolled/treated subjects will receive the LEGION Hinge Knee System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Original Knee Society Clinical Score© (KSCS) | The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The KSCS will be administered at the pre-operative visit and all follow-up visits. The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years. | 1 year |
| Revision | Revision, for any reason, will be assessed throughout the subject's participation in the study. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Original Knee Society Functional Score© (KSFS) | The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring a revision total knee arthroplasty (TKA) using the LEGION Hinge Total Knee system.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals | Iowa City | Iowa | 52242 | United States | ||
| NYU Hospital for Joint Diseases |
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| Original Knee Society Functional Score© (KSFS) | The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years. | 2 years |
| 2011 Knee Society Score© | 2011 Knee Society Knee Score and all of it's components | 1 year |
| 2011 Knee Society Score© | 2011 Knee Society Knee Score and all of it's components | 2 years |
| EQ-5D-3L™ | The EuroQol EQ-5D-3L™ is a descriptive system measuring health-related Quality Of Life (QOL) and consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D-3L™ dimension. The EQ-5D-3L™ is completed by the Subject on the day of their visit. | 1 year |
| EQ-5D-3L™ | The EuroQol EQ-5D-3L™ is a descriptive system measuring health-related Quality Of Life (QOL) and consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D-3L™ dimension. The EQ-5D-3L™ is completed by the Subject on the day of their visit. | 2 years |
| Original Knee Society Clinical Score© (KSCS) | The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The KSCS will be administered at the pre-operative visit and all follow-up visits. The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years. | 2 Years |
| New York |
| New York |
| 10003 |
| United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Fremantle Hospital | Fremantle | Western Australia | 6160 | Australia |
| UZ Leuven campus Pellenberg | Pellenberg | 3212 | Belgium |
| Concordia Hip and Knee Institute | Winnipeg | Manitoba | R2K 2M9 | Canada |
| University Hospital Mutua de Terrassa | Terrassa | Barcelona | 08221 | Spain |