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

Completed

• Conditions: Early-Onset Scoliosis Deformity of Spine
• Interventions: Combination Product: Growth-sparing instrumentation and titanium levels

• Registration Number: NCT04069637
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Study Start: 2019-11-07
• Status Verified: 2022-07
• Primary Completion: 2022-07-19
• Study Completion: 2022-07-19
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early onset Scoliosis	Growth-sparing instrumentation and titanium levels	Patients with early onset scoliosis treated with growth-sparing instrumentation (TGR, MCGR, and, VEPTR).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States