Serum and Urine Titanium Levels in Children With Early Onset Scoliosis Treated With Growth-Sparing Instrumentation
|ClinicalTrials.gov Identifier: NCT04069637|
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2019
Last Update Posted : November 12, 2019
|Condition or disease||Intervention/treatment|
|Early-Onset Scoliosis Deformity of Spine||Combination Product: Growth-sparing instrumentation and titanium levels|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||37 participants|
|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|
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.
Patients with operative fractures.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069637
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48109|