Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT02315729

Conditions

Adolescent Idiopathic Scoliosis

Eligibility Criteria

Sex: Female

Age: 10 - 13

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Adolescent Idiopathic Scoliosis

Study ID

NCT02315729

Start date

Nov, 2016

Status verified date

Sep, 2023

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 10 - 13

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

380 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Scoliosis Curve Progression [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

jiandong hao

303-724-7457jiandong.hao@cuanschutz.edu

Locations

Children'S Hospital of Colorado

Recruiting

Denver, Colorado, United States, 80045

Contacts

jiandong hao

303-724-7457jiandong.hao@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2023-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.