Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis

Scoliosis Clinical Trial

Official title:

Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02819245
• Other study ID #: 2003-01-15-scoliosis
• Status: Recruiting
• Phase: N/A
• First received: June 24, 2016
• Last updated: June 27, 2016
• Start date: January 2003

Study information

• Verified date: June 2016
• Source: Nanjing University School of Medicine
• Contact: Hongda Bao
• Phone: 6463872363
• Email: baohongda123[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Jiangsu Provincial Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial Summary

This is a study prospectively enrolling adolescent idiopathic scoliosis (AIS) patients and try to find how the age will impact the surgical outcome of AIS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 25 Years

Eligibility

Inclusion Criteria:

• Adolescent idiopathic scoliosis patients; undergoing posterior correction surgery; with minimum 5 years follow-up; with full-spine radiography.

Exclusion Criteria:

• with spinal tumor; with hip disease; without quality of life measurements.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scoliosis

Intervention

Procedure:
• posterior correction and fusion

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of coronal Cobb angle	Cobb angles, including thoracic and lumbar Cobb angle, are measured from coronal radiographs with validated software (Surgimap).	From immediate post-operative until at least 10 years follow-up	No
Secondary	Improvement of sagittal profile	Sagittal profile, described sagittal radiographic parameters such as thoracic kyphosis and lumbar lordosis, is measured with validated software (Surgimap).	From immediate post-operative until at least 10 years follow-up	No
Secondary	Health-related quality of life (HRQOL)	HRQOL measurements include Short Form 36 (SF-36), Scoliosis Research Society (SRS) 22 questionnaire and Visual Analogue Scale (VAS).	From immediate post-operative until at least 10 years follow-up	No