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Enrolling by Invitation

NCT Number: NCT06447922

Metal Ion Concentrations After Total Knee Arthroplasty

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA)

    Time frame: 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 outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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