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

Study Overview
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Brief Summary
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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.

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

Conditions
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Early-Onset Scoliosis Deformity of Spine

Intervention / Treatment
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* Combination Product: Growth-sparing instrumentation and titanium levels


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases: Patients with early onset scoliosis treated with traditional growing rods (TGR), magnetically controlled growing rods (MCGR), and the Vertical Expandable Prosthetic Titanium Rib (VEPTR). Controls: Patients with operative fractures. Exclusion Criteria: Cases: Patients who had a previous limited spinal fusion, conversion from one type of GSI to another, TGR with stainless steel or cobalt chromium instrumentation, and indwelling implants for 6 months or less. Controls: Patients with indwelling implants or prior implant insertion and removal.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early onset Scoliosis<br>Patients with early onset scoliosis treated with growth-sparing instrumentation (TGR, MCGR, and, VEPTR). | Combination Product: Growth-sparing instrumentation and titanium levels<br>* 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.<br>|
| Control group<br>Patients with operative fractures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum titanium levels between groups | Compare serum titanium levels in patients with EOS treated with titanium alloy TGR, MCGR, and VEPTR to age-matched controls. | At enrollment | 
| Serial serum titanium levels in scoliosis patients | Collect serial serum titanium levels in patients with EOS treated with TGR, MCGR, and VEPTR. | Roughly 6 months apart | 
| Urine titanium levels in scoliosis patients | Collect urine titanium levels in patients with EOS treated with TGR, MCGR, and VEPTR. | At enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Titanium Levels