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The purpose of this study is to analyze the metal ion concentrations in the patients blood following robotic-assisted total knee arthroplasty (TKA) compared to conventional total knee arthroplasty using cutting guides.
This study focuses on comparing metal ion levels in 50 inpatient participants undergoing primary total knee arthroplasty (TKA) with either conventional cutting guides or robotic assistance. Baseline blood examinations for Cobalt, Chromium, Titanium, and Nickel will be performed before TKA implantation at preoperative visits and on the first day following the procedure. The investigation will encompass patients receiving both conventional and robotic-assisted primary TKA, framed within a prospective cohort study design. Baseline characteristics and additional follow-up information will be gathered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional TKA with Cutting Guides | Patients undergoing a conventional total knee arthroplasty with cutting guides (no robot-assistance). |
| |
| Robot-Assisted TKA | Patients undergoing a robot-assisted total knee arthroplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metal ion level testing | Other | Patients will undergo a pre- and post-operative blood draw to analyze metal ion levels (Cobalt, Chromium, Titanium and Nickel) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA) | Difference in overall blood metal ion levels (Cobalt, Chromium, Titanium, and Nickel) between patients undergoing total knee arthroplasty (TKA) with conventional cutting guides and those undergoing TKA with robotic assistance. | Pre-operatively, first post-operative day. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of post-operative blood metal levels between procedures: Cobalt | Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA | First post-operative day |
| Comparison of post-operative blood metal levels between procedures: Chromium |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients eligible for a primary total knee replacement who have not had a prior joint replacement or surgery where metal implants were placed.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew P Abdel | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA |
| First post-operative day |
| Comparison of post-operative blood metal levels between procedures: Titanium | Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA | First post-operative day |
| Comparison of post-operative blood metal levels between procedures: Nickel | Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA | First post-operative day |