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Decision of investigational team
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This is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee Replacement (TKR) in the last 6 months) will be involved in the study. To complete the study protocol, the center will collect baseline surgical and training data on 10 "off-the-shelf" TKR patients using the implant system the surgeon currently uses. Then the first 50 consecutive patients who have been identified to receive the iTotal implant (Cruciate-Retaining or Posterior-Stabilizing) based on patient factors and the implant system IFU will be enrolled in the study. Simultaneous bilateral Total Knee Arthroplasty cases will be excluded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Off-the-Shelf Total Knee Arthroplasty Patients |
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| Conformis iTotal Total Knee Arthroplasty Patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Off-the-Shelf Implant Total Knee Replacement | Device | Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Off-the-Shelf implants use standard sizing. |
| Measure | Description | Time Frame |
|---|---|---|
| Operating Room Efficiency | Surgeon questionnaire to determine operating room efficiency from the 1st to the 50th iTotal implant performed and to determine any differences that might exist between operating room efficiency between the iTotal surgery and baseline metrics when performing OTS implant surgery | Single time point - day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients receiving Total Knee Arthroplasty
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kettering Medical Center | Kettering | Ohio | 45429 | 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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| Customized Implant Total Knee Replacement | Device | Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Customized implants are customized individually made knee implants which are designed specific to each patient's unique anatomy. |
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| D012216 |
| Rheumatic Diseases |