Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01760434
Enrollment
66
Registered
2013-01-04
Start date
2013-01-31
Completion date
2015-10-31
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis

Keywords

scoliosis, long-term outcomes, sagittal plane, quality of life, curve progression, pulmonary function

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.

Interventions

OTHERLong-term outcomes

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.

Sponsors

Scoliosis Research Society
CollaboratorOTHER
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cobb angle and sagittal plane alignment20 yearsCobb angle and sagittal plane alignment at minimum 20 year follow-up after bracing, surgery or observation for adolescent idiopathic scoliosis
Scoliosis curve magnitudeNov. 2014

Secondary

MeasureTime frameDescription
Pulmonary function testing20 yearsPulmonary 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 lifeNov. 2014

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026