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Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02819245
Recruitment Status : Unknown
Verified June 2016 by Hongda Bao, Nanjing University School of Medicine.
Recruitment status was:  Recruiting
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Hongda Bao, Nanjing University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Scoliosis Procedure: posterior correction and fusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis
Study Start Date : January 2003
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Age before and after 18 years old
Surgical treatment before and after skeletal maturity
Procedure: posterior correction and fusion



Primary Outcome Measures :
  1. Improvement of coronal Cobb angle [ Time Frame: From immediate post-operative until at least 10 years follow-up ]
    Cobb angles, including thoracic and lumbar Cobb angle, are measured from coronal radiographs with validated software (Surgimap).


Secondary Outcome Measures :
  1. Improvement of sagittal profile [ Time Frame: From immediate post-operative until at least 10 years follow-up ]
    Sagittal profile, described sagittal radiographic parameters such as thoracic kyphosis and lumbar lordosis, is measured with validated software (Surgimap).

  2. Health-related quality of life (HRQOL) [ Time Frame: From immediate post-operative until at least 10 years follow-up ]
    HRQOL measurements include Short Form 36 (SF-36), Scoliosis Research Society (SRS) 22 questionnaire and Visual Analogue Scale (VAS).



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819245


Contacts
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Contact: Hongda Bao 6463872363 baohongda123@gmail.com

Locations
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China, Jiangsu
Nanjing Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Hongda Bao    6463872363    baohongda123@gmail.com   
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
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Study Chair: Yong Qiu The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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Responsible Party: Hongda Bao, Resident and research scientist, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT02819245    
Other Study ID Numbers: 2003-01-15-scoliosis
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases