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NCT04069637 · ClinicalTrials.gov registry record
Serum and Urine Titanium Levels in Children With Early Onset Scoliosis Treated With Growth-Sparing Instrumentation
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 38
- Enrollment target
NCT04069637: Completed study, sponsored by University of Michigan.
NCT04069637 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04069637 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 38 participants
- Enrollment target
Study 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.
Primary Outcome
Compare serum titanium levels in patients with EOS treated with titanium alloy TGR, MCGR, and VEPTR to age-matched controls.
Interventions
- COMBINATION_PRODUCT Growth-sparing instrumentation and titanium levels
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-11-07 |
| Est. Completion | 2022-07-19 |
What the finished NCT04069637 record still lists
NCT04069637 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Growth-sparing instrumentation and titanium levels is the first listed.
NCT04069637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04069637 about?
NCT04069637 is a clinical study titled "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 Expa...
What is the current status of trial NCT04069637?
This trial is currently completed. The enrollment target is 38 participants. The study started on 2019-11-07. Estimated completion is 2022-07-19.
What interventions are being tested in trial NCT04069637?
The interventions under investigation include: Growth-sparing instrumentation and titanium levels (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04069637?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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