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Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis

Primary Purpose

Scoliosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
posterior correction and fusion
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis

Eligibility Criteria

10 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing Drum Tower HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Age before and after 18 years old

Arm Description

Surgical treatment before and after skeletal maturity

Outcomes

Primary Outcome Measures

Improvement of coronal Cobb angle
Cobb angles, including thoracic and lumbar Cobb angle, are measured from coronal radiographs with validated software (Surgimap).

Secondary Outcome Measures

Improvement of sagittal profile
Sagittal profile, described sagittal radiographic parameters such as thoracic kyphosis and lumbar lordosis, is measured with validated software (Surgimap).
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).

Full Information

First Posted
June 24, 2016
Last Updated
June 27, 2016
Sponsor
Nanjing University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02819245
Brief Title
Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis
Official Title
Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Age before and after 18 years old
Arm Type
Other
Arm Description
Surgical treatment before and after skeletal maturity
Intervention Type
Procedure
Intervention Name(s)
posterior correction and fusion
Primary Outcome Measure Information:
Title
Improvement of coronal Cobb angle
Description
Cobb angles, including thoracic and lumbar Cobb angle, are measured from coronal radiographs with validated software (Surgimap).
Time Frame
From immediate post-operative until at least 10 years follow-up
Secondary Outcome Measure Information:
Title
Improvement of sagittal profile
Description
Sagittal profile, described sagittal radiographic parameters such as thoracic kyphosis and lumbar lordosis, is measured with validated software (Surgimap).
Time Frame
From immediate post-operative until at least 10 years follow-up
Title
Health-related quality of life (HRQOL)
Description
HRQOL measurements include Short Form 36 (SF-36), Scoliosis Research Society (SRS) 22 questionnaire and Visual Analogue Scale (VAS).
Time Frame
From immediate post-operative until at least 10 years follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongda Bao
Phone
6463872363
Email
baohongda123@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Qiu
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongda Bao
Phone
6463872363
Email
baohongda123@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis

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