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NCT06447922 Clinical Trial

Metal Ion Concentrations After Total Knee Arthroplasty

Arthroplasty, Replacement, Knee Clinical Trial

Official title:
Analysis of Metal Ion Concentrations After Robotic-assisted Total Knee Arthroplasty Compared to Conventional Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06447922
Other study ID # 24-004661
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date June 2025

Study information
Verified date June 2024
Source Mayo Clinic
Contact Emilee J Andersen, M.A.
Phone (507) 266-9807
Email andersen.emilee@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Metal ion level testing
Patients will undergo a pre- and post-operative blood draw to analyze metal ion levels (Cobalt, Chromium, Titanium and Nickel)

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood Metal Ion Differences Between Procedures Difference in 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. Metal ion levels will be tested in patients pre-operatively and on the first post-operative day.
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