Status:

ENROLLING_BY_INVITATION

Metallosis on Tissues and Serum Metal Levels in Children

Lead Sponsor:

Mayo Clinic

Conditions:

Orthopedic Disorder

Retained Metal Implant

Eligibility:

All Genders

4-18 years

Brief Summary

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 ...

Detailed Description

Metal implants are routinely placed in children for treatment of fracture or deformity. Long-term effects of indwelling metal implants are not well-understood. Data from this study will provide guidan...

Eligibility Criteria

Inclusion

  • Ages 4 years - 18 years
  • Stainless steel, titanium or titanium-alloy based implants, scheduled for surgery
  • De novo surgery where titanium implant placement

Exclusion

  • Concomitant infection

Key Trial Info

Start Date :

December 1 2017

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT03359109

Start Date

December 1 2017

End Date

September 1 2026

Last Update

November 4 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

2

Sanford Health

Sioux Falls, South Dakota, United States, 57117

Metallosis on Tissues and Serum Metal Levels in Children | DecenTrialz