Metal Ion Concentrations After Total Knee Arthroplasty

NCT06447922 | Active Not Recruiting

• 1 other identifier: 24-004661
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee; Total Knee Replacement; Blood Metal Ion Concentration

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Comparison of post-operative blood metal levels between procedures: Cobalt

  First post-operative day

• Comparison of post-operative blood metal levels between procedures: Chromium

  First post-operative day

• Comparison of post-operative blood metal levels between procedures: Titanium

  First post-operative day

• Comparison of post-operative blood metal levels between procedures: Nickel

  First post-operative day

Study Arms (2)

Conventional TKA with Cutting Guides

Patients undergoing a conventional total knee arthroplasty with cutting guides (no robot-assistance).

Other: Metal ion level testing

Robot-Assisted TKA

Patients undergoing a robot-assisted total knee arthroplasty.

Other: Metal ion level testing

Interventions

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)

Conventional TKA with Cutting Guides; Robot-Assisted TKA

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients eligible for a primary total knee replacement who have not had a prior joint replacement or surgery where metal implants were placed.

You may qualify if:

• Adults undergoing conventional or robotic-assisted TKA
• Consent to the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Matthew P Abdel

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)