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Challenging enrollment due to COVID-19.
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This is a prospective, single-center clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona Total Knee components using the ROSA Total Knee Robotic System or conventional instrumentation.
The primary objective of this study is to collect and compare clinical outcomes and surgical data using the ROSA Total Knee robotic instrumentation and conventional instrumentation in primary total knee arthroplasty.
The assessments will include: Planned vs actual component positioning; Workflow efficiency; Patient safety based on incidence and frequency of adverse events; Clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Assisted TKA | Active Comparator | Robotic Assisted TKA via ROSA Robot |
|
| Conventional TKA | Active Comparator | Conventional TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PERSONA Total Knee | Device | Primary Total Knee Arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D questionnaire | EQ-5D | 1 year |
| Oxford Knee Score Questionnaire | Oxford Knee Score | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Jaggard | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
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| ID | Term |
|---|---|
| D056304 | Genu Valgum |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| D012216 |
| Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |