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

NCT04069637 | Completed FDA Device

• 1 other identifier: HUM00163421
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Early-Onset Scoliosis Deformity of Spine

Keywords

Titanium Levels

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Urine titanium levels in scoliosis patients

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

  At enrollment

Study Arms (2)

Early onset Scoliosis

Patients with early onset scoliosis treated with growth-sparing instrumentation (TGR, MCGR, and, VEPTR).

Combination Product: Growth-sparing instrumentation and titanium levels

Control group

Patients with operative fractures.

Interventions

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.

Early onset Scoliosis

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be patients treated by the Pediatric Orthopaedic Surgery department at Michigan Medicine.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Scoliosis Research Society: collaborator

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Of Orthopaedic Surgery

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: November 7, 2019
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)