Early-Onset Scoliosis Deformity of SpineNCT04069637
Serum and Urine Titanium Levels in Children With Early Onset Scoliosis Treated With Growth-Sparing Instrumentation
An observational study of Early-Onset Scoliosis Deformity of Spine, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Early-Onset Scoliosis Deformity of Spine
- What is being tested?
- Growth-sparing instrumentation and titanium levels
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2019to 19 Jul 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will be patients treated by the Pediatric Orthopaedic Surgery department at Michigan Medicine.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Growth-sparing instrumentation and titanium levels
- Keywords
- Titanium Levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth-sparing instrumentation and titanium levelsCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Early onset Scoliosis | Patients with early onset scoliosis treated with growth-sparing instrumentation (TGR, MCGR, and, VEPTR). Receives: Combination Product: Growth-sparing instrumentation and titanium levels | |
| Control group | Patients with operative fractures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Serial serum titanium levels in scoliosis patients
Collect serial serum titanium levels in patients with EOS treated with TGR, MCGR, and VEPTR.
Measured: Roughly 6 months apart
Urine titanium levels in scoliosis patients
Collect urine titanium levels in patients with EOS treated with TGR, MCGR, and VEPTR.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start7 Nov 2019
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Onset Scoliosis Deformity of SpineStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Scoliosis Research Society
- Responsible party
- Principal investigator, G Ying Li, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069637
- Sponsor's protocol ID
- HUM00163421
- Status last verified
- Jul 2022
- First submitted
- 23 Aug 2019
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum and Urine Titanium Levels in Children With Early Onset Scoliosis Treated With Growth-Sparing Instrumentation
- ClinicalTrials.gov ID
- NCT04069637
- Acronym / sponsor ID
- HUM00163421
- Conditions
- Early-Onset Scoliosis Deformity of Spine
- Keywords
- Titanium Levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Scoliosis Research Society
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early onset Scoliosis | – | Combination Product: Growth-sparing instrumentation and titanium levelsPatients with early onset scoliosis treated with growth-sparing instrumentation (TGR, MCGR, and, VEPTR). |
| Control group | – | –Patients with operative fractures. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will be patients treated by the Pediatric Orthopaedic Surgery department at Michigan Medicine.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth-sparing instrumentation and titanium levelsPatients 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. | Combination product | Early onset Scoliosis |
Primary outcome
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.
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.
Urine titanium levels in scoliosis patients
Time frame: At enrollment
Collect urine titanium levels in patients with EOS treated with TGR, MCGR, and VEPTR.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early-Onset Scoliosis Deformity of Spine, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum titanium levels between groups (time frame: At enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.