Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Adolescent Idiopathic Scoliosis. Basic parameters: 10 years — 13 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Scoliosis Curve Progression [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Females aged 10-13 years
- Diagnosed with mild-moderate spine deformity (Cobb angle 15-30 degrees)
Exclusion criteria
- Patients with scoliosis other than idiopathic
- Trauma
- Inflammatory disease
- Malignancies
- Diabetes
- History of previous spine surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children'S Hospital of Colorado — Denver
Identifiers
NCT: NCT02315729 · 14-0884 · UL1TR001082