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The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device.
This study is a retrospectively enrolled, prospective evaluation of the Triathlon All-Polyethylene Tibia (APT) for patients who meet the eligibility criteria. The enrolled cases will be followed for outcomes measured to 10 years. A modular, Triathlon metal-backed tibia (MBT) and polyethylene insert construct will be used as a historical control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triathlon All-Polyethylene Tibia Knee | Other | All subjects enrolled will have received the Triathlon All-Polyethylene Tibia Knee device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon All-Polyethylene Tibia Knee | Device | Triathlon All-Polyethylene Tibia Knee is an all polyethylene resurfacing knee device using either a condylar stabilizing (CS) and posterior stabilizing (PS) device. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score (KSS) Function | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome postoperative. | 10-years postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Survival Analysis | To present 10-year Kaplan-Meier survival analysis for the Triathlon APT | 10-years postoperative |
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Inclusions:
Exclusions:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Orthopaedic Center | Lansing | Michigan | 48910 | United States | ||
| Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital |
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| Buffalo |
| New York |
| 14203 |
| United States |
| Syracuse Orthopedic Specialists, PC | Syracuse | New York | 13214 | United States |
| Duke University Medical Center | Durham | North Carolina | 27703 | United States |
| Department of Orthopaedic Surgery Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Musculoskeletal Institute, University of Texas Health Austin | Austin | Texas | 78712 | United States |