Long-Term Outcome Following the Treatment of Pediatric Scoliosis
Prospective Study: Long-Term Pulmonary Function, Health-Related Quality of Life, and Sagittal Plane Alignment Following the Treatment of Pediatric Scoliosis
1 other identifier
interventional
66
1 country
1
Brief Summary
Evaluate the long-term outcomes following operative and nonoperative treatment of childhood scoliosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
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, 2013
CompletedFirst Submitted
Initial submission to the registry
January 2, 2013
CompletedFirst Posted
Study publicly available on registry
January 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMarch 19, 2019
March 1, 2019
2.7 years
January 2, 2013
March 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cobb angle and sagittal plane alignment
Cobb angle and sagittal plane alignment at minimum 20 year follow-up after bracing, surgery or observation for adolescent idiopathic scoliosis
20 years
Scoliosis curve magnitude
Nov. 2014
Secondary Outcomes (2)
Pulmonary function testing
20 years
Health-related quality of life
Nov. 2014
Study Arms (1)
Long-Term Outcomes
OTHERPatients will be recruited who were diagnosed with adolescent idiopathic scoliosis prior to age 18 and before 1994 (minimum 20 year outcomes) with available xrays. Patients will be included who were treated with surgery, observation, or bracing. Patients will return for a one-time visit for new xrays, physical exam, health-related quality of life surveys, and pulmonary function testing.
Interventions
Patients with a history of adolescent idiopathic scoliosis will return at a minimum of 20 year follow-up for new spine xrays, clinical exam, pulmonary function testing, and assessment of health related quality of life based on survey responses.
Eligibility Criteria
You may qualify if:
- Diagnosis of adolescent idiopathic scoliosis made before age 18
- Diagnosis of adolescent idiopathic scoliosis prior to 1994
- Treatment with bracing, observation, or surgery prior to age 18 and 1994
- Adequate radiographs/medical records available from time of diagnosis
You may not qualify if:
- Neuromuscular scoliosis
- Syrinx
- Inadequate radiographs/medical records available from time of diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Scoliosis Research Societycollaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annalise Noelle Larson, MD
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Michael J. Yaszemski, MD, PhD
Mayo Clinic
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
- Co-Principal Investigator
Study Record Dates
First Submitted
January 2, 2013
First Posted
January 4, 2013
Study Start
January 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 19, 2019
Record last verified: 2019-03