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Metal Ion Concentrations After Total Knee Arthroplasty

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Mayo Clinic

Status

Active, not recruiting

Conditions

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

Treatments

Other: Metal ion level testing

Study type

Observational

Funder types

Other

Identifiers

NCT06447922
24-004661

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Conventional TKA with Cutting Guides
Description:
Patients undergoing a conventional total knee arthroplasty with cutting guides (no robot-assistance).
Treatment:
Other: Metal ion level testing
Robot-Assisted TKA
Description:
Patients undergoing a robot-assisted total knee arthroplasty.
Treatment:
Other: Metal ion level testing

Trial contacts and locations

1

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Central trial contact

Gabe Schouten; Kelly Sonsalla, M.B.A.

Data sourced from clinicaltrials.gov

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