Metallosis on Tissues and Serum Metal Levels in Children

October 31, 2025 updated by: A. Noelle Larson, MD, Mayo Clinic

Effect of Metallosis on Tissues and Serum Metal Levels in Children With Orthopedic Implants

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.

Study Overview

Status

Enrolling by invitation

Conditions

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 guidances as to whether some metals are safer for children (stainless vs. titanium alloys). In addition, we will document the presence of serum ion concentration for children with metal implants in place and whether this resolves after implant removal. Tissues adjacent to implants will be evaluated for signs of metallosis and wear debris. Presence of metallosis will be correlated with serum ion concentration. In vivo studies will provide data on whether metal exposure to bone cells and fibroblasts affects their inflammatory cascade and function. Based on these findings, surgeons can better counsel patients whether routine implant removal is advisable or whether stainless steel implants are safer for long-term retention compared to titanium implants. Further, novel drug targets for treatment and prevention of metallosis will be developed. This project will foster collaboration and future partnerships between the Sanford Health and Mayo Clinic research teams

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Pediatric patients undergoing orthopedic surgery to remove or place metal implants.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Concomitant infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanistic responses of bone repair cells upon Ti exposure
Time Frame: 3-6 months
To address how deregulated bone repair provokes adverse reactions, the investigators will monitor gene regulatory effects in cell culture models of titanium exposure by either silencing or activating key biological pathways
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate serum levels of metal ions
Time Frame: 3-6 months
To evaluate systemic effects of metal ions on children, the investigators will determine whether metal ion levels are elevated in participants with retained implants by intraoperatively blood draw and at first postoperatively visit. Conversely, participants undergoing implant placement will also have ion levels taken intraoperatively and then at latest follow-up visit to see if implants cause in increase in serum metal levels
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: A.Noelle Larson, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

December 2, 2017

Study Record Updates

Last Update Posted (Estimated)

November 4, 2025

Last Update Submitted That Met QC Criteria

October 31, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-004970

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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