NCT00445393

Brief Summary

The purpose of this pilot study is to determine the presence, frequency, and severity of mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 6, 2009

Status Verified

January 1, 2009

First QC Date

March 7, 2007

Last Update Submit

January 5, 2009

Conditions

Scoliosis

Keywords

ObservationMental healthScoliosisScreeningAdolescent idiopathic scoliosis

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Aadolescents undergoing spinal surgery for scoliosis.

You may not qualify if:

  • All types of scoliosis besides AIS will be excluded. This includes neuromuscular, congenital, infantile idiopathic, and childhood idiopathic scoliosis.
  • Children younger than eleven years or older than sixteen years will be excluded.
  • Those with additional chronic disease will be excluded, due to the possibility of confounding.
  • Those unable to complete the entire questionnaire, for any reason, or those unable to complete the questionnaires at each time point will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital - Dept of Orthopaedics

Vancouver, British Columbia, V6H3V4, Canada

Location

MeSH Terms

Conditions

ScoliosisPsychological Well-Being

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesPersonal SatisfactionBehavior

Study Officials

  • Christopher Reilly, MD, FRCSC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Darin Davidson, MD, PGYIII

    University of British Columbia

    STUDY DIRECTOR

  • Jane Garland, MD

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 9, 2007

Study Start

October 1, 2006

Study Completion

October 1, 2008

Last Updated

January 6, 2009

Record last verified: 2009-01

Locations

CA(1)