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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 : August 19, 2022
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.


Condition or disease
Adolescent Idiopathic Scoliosis

Study Design
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Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis
Study Start Date : November 2016
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Scoliosis Curve Progression [ Time Frame: 3 years ]
    Cobb angle, disc wedging, vertebral body wedging, coronal balance, sagittal balance


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients with adolescent idiopathic scoliosis
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Claire Cofer 303-724-1588

Locations
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United States, Colorado
Recruiting
Denver, Colorado, United States
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Evalina L Burger, MD University of Colorado - Anschutz Medical Campus
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02315729    
Other Study ID Numbers: 14-0884
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: August 19, 2022
Last Verified: August 2022
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases