Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02315729
• Other study ID #: 14-0884
• Secondary ID: UL1TR001082
• Status: Recruiting
• Start date: November 2016
• Est. completion date: December 2028

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: jiandong hao
• Phone: 303-724-7457
• Email: jiandong.hao[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: December 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Locations

Country	Name	City	State
United States	Children'S Hospital of Colorado	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scoliosis Curve Progression	Cobb angle, disc wedging, vertebral body wedging, coronal balance, sagittal balance	3 years