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Metallosis on Tissues and Serum Metal Levels in Children

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ClinicalTrials.gov Identifier: NCT03359109
Recruitment Status : Enrolling by invitation
First Posted : December 2, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
A. Noelle Larson, Mayo Clinic

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.

Condition or disease
Orthopedic Disorder Retained Metal Implant

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Metallosis on Tissues and Serum Metal Levels in Children With Orthopedic Implants
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Waste Surgical Tissue, possible cell-line development


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric patients undergoing orthopedic surgery to remove or place metal implants.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359109


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, South Dakota
Sanford Health
Sioux Falls, South Dakota, United States, 57117
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: A.Noelle Larson, MD Mayo Clinic

Additional Information:
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Responsible Party: A. Noelle Larson, Associate Professor of Orthopedics, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03359109     History of Changes
Other Study ID Numbers: 17-004970
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Musculoskeletal Diseases