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

Early-Onset Scoliosis Deformity of Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069637
• Other study ID #: HUM00163421
• Status: Completed
• Start date: November 7, 2019
• Est. completion date: July 19, 2022

Study information

• Verified date: July 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early-Onset Scoliosis Deformity of Spine
• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
United States	Michigan Medicine	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Scoliosis Research Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Urine titanium levels in scoliosis patients	Collect urine titanium levels in patients with EOS treated with TGR, MCGR, and VEPTR.	At enrollment