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Clinical Trials/NCT02315729
NCT02315729RecruitingNot Applicable

Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis

University of Colorado, Denver1 site in 1 country380 target enrollmentStarted: November 2016Last updated:
Conditions

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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