Status:

COMPLETED

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

Lead Sponsor:

University of Michigan

Collaborating Sponsors:

Scoliosis Research Society

Conditions:

Early-Onset Scoliosis Deformity of Spine

Eligibility:

All Genders

5-15 years

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 in...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 7 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 19 2022

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT04069637

Start Date

November 7 2019

End Date

July 19 2022

Last Update

July 22 2022

Active Locations (1)

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1

Michigan Medicine

Ann Arbor, Michigan, United States, 48109