- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04069637
Serum and Urine Titanium Levels in Children With Early Onset Scoliosis Treated With Growth-Sparing Instrumentation
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Michigan Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Early onset Scoliosis
Patients with early onset scoliosis treated with growth-sparing instrumentation (TGR, MCGR, and, VEPTR).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At enrollment
|
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.
|
Roughly 6 months apart
|
Urine titanium levels in scoliosis patients
Time Frame: At enrollment
|
Collect urine titanium levels in patients with EOS treated with TGR, MCGR, and VEPTR.
|
At enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00163421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Early-Onset Scoliosis Deformity of Spine
-
Assiut UniversityRecruitingEarly-Onset Scoliosis Deformity of SpineEgypt
-
Pediatric Spine FoundationColumbia UniversityRecruitingEarly-Onset Scoliosis Deformity of SpineUnited States, Canada, Finland, Hong Kong
-
University of IowaOrthopedic Research and Education Foundation; Pediatric Spine Study GroupRecruitingScoliosis Idiopathic | Early-Onset Scoliosis Deformity of SpineUnited States, Singapore, Hong Kong, United Kingdom, Canada, Italy, New Zealand, Turkey
-
UMC UtrechtApifixWithdrawnIdiopathic Scoliosis | Early-Onset Scoliosis Deformity of Spine (Disorder)Netherlands
-
Growing Spine Study GroupGrowing Spine FoundationCompletedEarly Onset Scoliosis | Thoracic Insufficiency Syndrome | Congenital Spinal Deformities | Infantile Idiopathic Scoliosis | Neuromuscular Spinal Deformity | Syndromic Spinal DeformityUnited States, Canada, United Kingdom, Egypt, Ghana, Spain, Turkey
-
AO Innovation Translation CenterActive, not recruitingEarly Onset ScoliosisUnited Kingdom, Switzerland
-
EVEREST PESQUISA E DESENVOLVIMENTO LTDANot yet recruiting
-
Boston Children's HospitalChildren's Hospital Colorado; Cedars-Sinai Medical Center; Hospital for Special... and other collaboratorsRecruitingAdolescent Idiopathic Scoliosis | Idiopathic Scoliosis | Spondylolisthesis | Spine Deformity | Neuromuscular Scoliosis | Congenital ScoliosisUnited States
-
University of VirginiaHemoSonics LLCCompleted
-
SI-BONE, Inc.RecruitingSpinal Fusion | Deformity of SpineUnited States
Clinical Trials on Growth-sparing instrumentation and titanium levels
-
Central Hospital, Nancy, FranceCompleted
-
Istituto Ortopedico RizzoliRecruitingOsteoarthritis, Hip | Osteoporotic Fracture of FemurItaly
-
Turkish Ophthalmology SocietyCompleted
-
Centre Antoine LacassagneInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedMetastatic Kidney CancersFrance
-
Queen Fabiola Children's University HospitalUnknown
-
Hunan Cancer HospitalCompletedMetastatic Colorectal AdenocarcinomaChina
-
The University of Texas Health Science Center at...National Center for Research Resources (NCRR)RecruitingGrowth Hormone Deficiency | Chromosome Aberrations | HypomyelinationUnited States
-
Dar El Oyoun HospitalCompletedCentral Serous ChorioretinopathyEgypt
-
Kazakhstan's Medical University "KSPH"Vyacheslav Notanovich Lokshin; Nurgalieva Zhanar Zhenisovna; Manzhuova Lyazzat... and other collaboratorsCompletedChild Development | Health Status | Children Born After Assisted Reproductive TechnologiesKazakhstan
-
Hospital de Clinicas de Porto AlegreCompleted