Metallosis on Tissues and Serum Metal Levels in Children
Effect of Metallosis on Tissues and Serum Metal Levels in Children With Orthopedic Implants
1 other identifier
observational
50
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2017
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedFirst Posted
Study publicly available on registry
December 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
November 4, 2025
October 1, 2025
8.8 years
November 27, 2017
October 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mechanistic responses of bone repair cells upon Ti exposure
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 Outcomes (1)
Evaluate serum levels of metal ions
3-6 months
Study Arms (3)
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
Eligibility Criteria
Pediatric patients undergoing orthopedic surgery to remove or place metal implants.
You may qualify if:
- Ages 4 years - 18 years
- Stainless steel, titanium or titanium-alloy based implants, scheduled for surgery
- De novo surgery where titanium implant placement
You may not qualify if:
- Concomitant infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Sanford Health
Sioux Falls, South Dakota, 57117, United States
Related Links
Biospecimen
Waste Surgical Tissue, possible cell-line development
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
A.Noelle Larson, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Orthopedics
Study Record Dates
First Submitted
November 27, 2017
First Posted
December 2, 2017
Study Start
December 1, 2017
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
November 4, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share