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Serum and Urine Titanium Levels in Children With Early Onset Scoliosis Treated With Growth-Sparing Instrumentation

NCT04069637 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2022-07-22

No results posted yet for this study

Summary

The investigators are conducting research to compare serum and urine titanium levels in children with early onset scoliosis who are being treated with certain types of metal spinal rods. These rods include traditional growing rods (TGR), magnetically-controlled growing rods (MCGR), and Vertical Expandable Prosthetic Titanium Rib (VEPTR). Children with metal rods may have elevated serum and urine titanium levels. These levels may remain elevated over time. The investigators will collect serum titanium levels from children with metal rods and children without metal rods to see if there are differences in their titanium levels. The investigators will then collect a second serum titanium level from children with metal rods at least 6 months later to see if the participants titanium levels remain elevated over time. The investigators will also collect urine titanium levels from children with metal rods to see if titanium is excreted in the urine.

Conditions

  • Early-Onset Scoliosis Deformity of Spine

Interventions

COMBINATION_PRODUCT

Growth-sparing instrumentation and titanium levels

Patients with growth-sparing instrumentation as treatment for early onset scoliosis, will have their titanium (serum and urine) levels tested, to evaluated if they have elevated titanium levels compared to a control group.

Sponsors & Collaborators

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2022-07-19
Completion
2022-07-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04069637 on ClinicalTrials.gov