Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- Scoliosis Curve Progression
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 13 Years (Child)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •Inflammatory disease
- •Malignancies
- •History of previous spine surgery
Outcomes
Primary Outcomes
Scoliosis Curve Progression
Time Frame: 3 years
Cobb angle, disc wedging, vertebral body wedging, coronal balance, sagittal balance
Secondary Outcomes
No secondary outcomes reported