Metallosis on Tissues and Serum Metal Levels in Children

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT03359109
Status
Enrolling By Invitation

Conditions

  • Orthopedic Disorder
  • Retained Metal Implant

Eligibility Criteria

Sex
ALL
Age
4 Years - 18 Years
Healthy Volunteers
Not accepted

Study Details

Slightly elevated blood metal levels have been found in adults undergoing hip and knee replacement. It is unknown whether pediatric patients with metal implant(plates/screws/rods) have elevated blood metal levels. This may have an impact on practice if children have high blood metal levels with routine orthopedic implants. If researchers find elevated metal levels, they may recommend patients to have the plates removed or may switch to a different type of metal. Further work on this topic is needed.

Key Dates

Start date
Dec 1, 2017
Status verified
Oct 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Stainless Steel Devices
    10 patients with stainless steel devices implanted
  • Arm: Titanium or Titanium-alloy Based Devices
    30 patients with titanium or titanium-alloy implanted devices
  • Arm: De Novo Titanium Implant
    10 patients undergoing de novo titanium implant placement who have had no previous orthopedic procedures

Primary Outcome Measure

Mechanistic responses of bone repair cells upon Ti exposure [ Time Frame: 3-6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-
Sanford HealthSioux FallsSouth Dakota57117-

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MNSanford Health· Sioux Falls, SD

Related Studies