Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis
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|ClinicalTrials.gov Identifier: NCT02315729|
Recruitment Status : Recruiting
First Posted : December 12, 2014
Last Update Posted : September 18, 2018
The purpose of this study is to identify potential markers for curve progression in adolescent idiopathic scoliosis (AIS). Despite its prevalence and impact on child health, the etiology of AIS and molecular mechanisms underlying its development and progression remain poorly understood. Clinical criteria and features cannot adequately predict which children, diagnosed with mild disease, will undergo subsequent curve progression requiring intervention.
The investigators hypothesize that alterations in specific genetic markers will be correlated with the progression of AIS curves over time. Thus, these markers could be used in the future to develop a reliable, inexpensive and relatively non-invasive cell based diagnostic test to (1) predict spinal curve progression in AIS, (2) select patients likely to benefit from early surgical intervention, and (3) potentially screen for asymptomatic children at risk of developing idiopathic scoliosis.
|Condition or disease|
|Adolescent Idiopathic Scoliosis|
|Study Type :||Observational|
|Estimated Enrollment :||380 participants|
|Official Title:||Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||April 2021|
- Scoliosis Curve Progression [ Time Frame: 3 years ]Cobb angle, disc wedging, vertebral body wedging, coronal balance, sagittal balance
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): NCT02315729
|Contact: Claire Cofer||303-724-1588|
|United States, Colorado|
|Denver, Colorado, United States|
|Principal Investigator:||Evalina L Burger, MD||University of Colorado - Anschutz Medical Campus|