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NCT Number: NCT02315729

Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis

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.

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Key information

Age range

10 year–13 year

Sex eligibility

Female

Study type

Observational

Primary location

Children'S Hospital of Colorado

Denver, Colorado, 80045, United States

Location status: Recruiting

Location contact

jiandong hao

CONTACT

[email protected]

303-724-7457

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Scoliosis Curve Progression

    Time frame: 3 years

    Cobb angle, disc wedging, vertebral body wedging, coronal balance, sagittal balance

Study contacts

Contact information is provided by the study sponsor or research team.

jiandong hao

CONTACT

[email protected]

303-724-7457

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2016
Primary completion
2025
Study completion
2028
First posted
Dec 12, 2014
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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