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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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To evaluate the non-inferiority of the cementless Engage Partial Knee System compared to cemented Engage Partial knee System.
Medial unicompartmental knee arthroplasty has demonstrated outstanding success in the treatment of anteromedial osteoarthritis of the knee. Most UKA implants in the US market require cemented fixation, and there can be specific complications related to cement such as aseptic loosening between the bone-cement and/or cement-implant interface along with loose cement causing third-body wear of the remaining normal articular cartilage. Cementless devices offer a durable long-term fixation method with no risk of loose cement causing secondary damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cemented Engage Partial Knee | Active Comparator | Engage partial knee implanted with bone cement for fixation. |
|
| Cementless Engage Partial Knee | Active Comparator | Engage partial knee implanted with cementless fixation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engage Partial Knee | Device | Unicompartmental knee arthroplasty utilizing the Engage Partial Knee system with bone cement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| KOOS JR Score | KOOS JR is a survey evaluating knee health for individuals following joint replacement by evaluating stiffness, pain, function, and activities of daily living. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Patient rated operative knee pain on a Likert pain score of 0-10. | 6 weeks; 3, 6, 9, 12 and 24 months |
| Range of Motion | Patient's range of motion is a measurement of the operated knee's extension and flexion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Crawford, MD | JIS Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JIS Research Institute | New Albany | Ohio | 43054 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Engage Partial Knee | Device | Unicompartmental knee arthroplasty utilizing the Engage Partial Knee system without bone cement. |
|
| 6 weeks; 3, 6, 9, 12 and 24 months |
| KOOS JR Score | KOOS JR is a survey evaluating knee health for individuals following joint replacement by evaluating stiffness, pain, function, and activities of daily living. | 6 weeks; 3, 6, 9, and 12 months |
| Implant Survivorship | Implant survivorship will be determined using revision surgery on the operated knee as implant failure. | 2 Year |
| D012216 |
| Rheumatic Diseases |