Arthroplasty, Replacement, Knee, Blood Metal Ion Concentration, Total Knee Replacement
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERMetal ion level testing
Patients will undergo a pre- and post-operative blood draw to analyze metal ion levels (Cobalt, Chromium, Titanium and Nickel)
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults undergoing conventional or robotic-assisted TKA * Consent to the study
Exclusion criteria
* Patients who have undergone any previous arthroplasty procedures. * Patients with metal implants, such as plates, nails, and screws, used in the repair of traumatic injuries. * Patients below 110 pounds.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA) | Pre-operatively, first post-operative day. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of post-operative blood metal levels between procedures: Cobalt | First post-operative day | Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA |
| Comparison of post-operative blood metal levels between procedures: Chromium | First post-operative day | Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA |
| Comparison of post-operative blood metal levels between procedures: Titanium | First post-operative day | Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA |
| Comparison of post-operative blood metal levels between procedures: Nickel | First post-operative day | Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew P Abdel
Mayo Clinic
Outcome results
None listed