Long-Term Outcome Following the Treatment of Pediatric Scoliosis
Primary Purpose
Adolescent Idiopathic Scoliosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Long-term outcomes
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring scoliosis, long-term outcomes, sagittal plane, quality of life, curve progression, pulmonary function
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Neuromuscular scoliosis
- Syrinx
- Inadequate radiographs/medical records available from time of diagnosis
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Long-Term Outcomes
Arm Description
Patients 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.
Outcomes
Primary Outcome Measures
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
Scoliosis curve magnitude
Secondary Outcome Measures
Pulmonary function testing
Pulmonary function testing will be performed at 20 years following bracing, observation or surgery for scoliosis to assess association between coronal and sagittal plane alignment and pulmonary function.
Health-related quality of life
Full Information
NCT ID
NCT01760434
First Posted
January 2, 2013
Last Updated
March 16, 2019
Sponsor
Mayo Clinic
Collaborators
Scoliosis Research Society
1. Study Identification
Unique Protocol Identification Number
NCT01760434
Brief Title
Long-Term Outcome Following the Treatment of Pediatric Scoliosis
Official Title
Prospective Study: Long-Term Pulmonary Function, Health-Related Quality of Life, and Sagittal Plane Alignment Following the Treatment of Pediatric Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Scoliosis Research Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the long-term outcomes following operative and nonoperative treatment of childhood scoliosis.
Detailed Description
The investigators hypothesize that sagittal alignment and thoracic volumes will predict successful treatment outcomes as measured by improved pulmonary function and health-related quality of life in adolescent idiopathic scoliosis patients at a minimum 20-year follow-up. Significant focus has been placed on the coronal plane in order to determine treatment indications for scoliosis, but with new understanding about the important of sagittal balance and pulmonary function, the treatment indications should be broadened. Thus, the investigators propose the following study to explore parameters associated with a durable and acceptable outcome following scoliosis treatment, minimizing the need for further surgery and to optimizing quality of life and pulmonary health. Beyond the standard radiographs and Scoliosis Research Society (SRS) scores, this study undertakes a comprehensive assessment of health-related quality of life, chest asymmetry and body satisfaction scoring, sagittal plane parameters, and 3D modeling of the childhood and current spinothoracic deformity. Thus, the investigators research team is uniquely poised to determine broader treatment indications for scoliosis. The overarching goal of this research effort is to determine new parameters based on thoracic volume and sagittal plane alignment in addition to coronal deformity in order to determine the appropriate treatment threshold for surgical intervention in children with adolescent idiopathic scoliosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
scoliosis, long-term outcomes, sagittal plane, quality of life, curve progression, pulmonary function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Long-Term Outcomes
Arm Type
Other
Arm Description
Patients 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.
Intervention Type
Other
Intervention Name(s)
Long-term outcomes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cobb angle and sagittal plane alignment
Description
Cobb angle and sagittal plane alignment at minimum 20 year follow-up after bracing, surgery or observation for adolescent idiopathic scoliosis
Time Frame
20 years
Title
Scoliosis curve magnitude
Time Frame
Nov. 2014
Secondary Outcome Measure Information:
Title
Pulmonary function testing
Description
Pulmonary function testing will be performed at 20 years following bracing, observation or surgery for scoliosis to assess association between coronal and sagittal plane alignment and pulmonary function.
Time Frame
20 years
Title
Health-related quality of life
Time Frame
Nov. 2014
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Neuromuscular scoliosis
Syrinx
Inadequate radiographs/medical records available from time of diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annalise Noelle Larson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J. Yaszemski, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Long-Term Outcome Following the Treatment of Pediatric Scoliosis
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