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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069637
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
Scoliosis Research Society
Information provided by (Responsible Party):
G Ying Li, University of Michigan

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.

Condition or disease Intervention/treatment
Early-Onset Scoliosis Deformity of Spine Combination Product: Growth-sparing instrumentation and titanium levels

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 37 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Serum and Urine Titanium Levels in Children With Early Onset Scoliosis Treated With Growth-Sparing Instrumentation
Actual Study Start Date : November 7, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.

Control group
Patients with operative fractures.



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will be patients treated by the Pediatric Orthopaedic Surgery department at Michigan Medicine.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069637


Locations
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United States, Michigan
Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Scoliosis Research Society
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Responsible Party: G Ying Li, Associate Professor Of Orthopaedic Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT04069637    
Other Study ID Numbers: HUM00163421
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by G Ying Li, University of Michigan:
Titanium Levels
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases