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Enrolling by invitation NCT06447922

Metal Ion Concentrations After Total Knee Arthroplasty

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metal ion level testing.
Who it may be relevant to
Registry conditions: Arthroplasty, Replacement, Knee, Total Knee Replacement, Blood Metal Ion Concentration. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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)

Primary outcome measures

  • Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA) [Time frame: Pre-operatively, first post-operative day.]
Secondary outcome measures (4)
  • Comparison of post-operative blood metal levels between procedures: Cobalt [Time frame: First post-operative day]
  • Comparison of post-operative blood metal levels between procedures: Chromium [Time frame: First post-operative day]
  • Comparison of post-operative blood metal levels between procedures: Titanium [Time frame: First post-operative day]
  • Comparison of post-operative blood metal levels between procedures: Nickel [Time frame: First post-operative day]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06447922 · 24-004661

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗