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Completed

NCT Number: NCT04069637

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

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.

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Key information

Conditions

Early-Onset Scoliosis Deformity of Spine

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Growth-sparing instrumentation and titanium levels

Combination Product

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.

Primary outcomes

  1. Serum titanium levels between groups

    Time frame: At enrollment

    Compare serum titanium levels in patients with EOS treated with titanium alloy TGR, MCGR, and VEPTR to age-matched controls.

  2. Serial serum titanium levels in scoliosis patients

    Time frame: Roughly 6 months apart

    Collect serial serum titanium levels in patients with EOS treated with TGR, MCGR, and VEPTR.

  3. Urine titanium levels in scoliosis patients

    Time frame: At enrollment

    Collect urine titanium levels in patients with EOS treated with TGR, MCGR, and VEPTR.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Scoliosis Research Society

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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