An observational study in Arthroplasty, Replacement, Knee, Total Knee Replacement and Blood Metal Ion Concentration, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Mayo Clinic · Observational
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.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients eligible for a primary total knee replacement who have not had a prior joint replacement or surgery where metal implants were placed.
Exclusion Criteria:
Patients undergoing a conventional total knee arthroplasty with cutting guides (no robot-assistance).
Other: Metal ion level testing
Patients undergoing a robot-assisted total knee arthroplasty.
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)
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.
Time frame: Pre-operatively, first post-operative day.
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
Time frame: First post-operative day
Comparison of post-operative blood metal levels between procedures: Chromium
Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA
Time frame: 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
Time frame: 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
Time frame: First post-operative day
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mayo Clinic