NCT02819245

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
13.5 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

June 30, 2016

Status Verified

June 1, 2016

Enrollment Period

15.9 years

First QC Date

June 24, 2016

Last Update Submit

June 27, 2016

Conditions

Scoliosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Improvement of sagittal profile

    From immediate post-operative until at least 10 years follow-up

  • Health-related quality of life (HRQOL)

    From immediate post-operative until at least 10 years follow-up

Study Arms (1)

Age before and after 18 years old

OTHER

Surgical treatment before and after skeletal maturity

Procedure: posterior correction and fusion

Interventions

posterior correction and fusionPROCEDURE
Age before and after 18 years old

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Scoliosis

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic Phenomena

Study Officials

  • Yong Qiu

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    STUDY CHAIR

Central Study Contacts

Hongda Bao

CONTACT

6463872363baohongda123@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident and research scientist

Study Record Dates

First Submitted

June 24, 2016

First Posted

June 30, 2016

Study Start

January 1, 2003

Primary Completion

December 1, 2018

Last Updated

June 30, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)