Early-Onset Scoliosis Deformity of Spine
Conditions
Keywords
Titanium Levels
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.
Interventions
COMBINATION_PRODUCTGrowth-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
Scoliosis Research Society
University of Michigan
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed