Long-Term Outcome Following the Treatment of Pediatric Scoliosis

Not Applicable

Completed

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Other: Long-term outcomes

• Registration Number: NCT01760434
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-16
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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Exclusion Criteria

• Neuromuscular scoliosis
• Syrinx
• Inadequate radiographs/medical records available from time of diagnosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Long-Term Outcomes	Long-term outcomes	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.

Primary Outcome Measures

Name	Time	Method
Cobb angle and sagittal plane alignment	20 years	Cobb angle and sagittal plane alignment at minimum 20 year follow-up after bracing, surgery or observation for adolescent idiopathic scoliosis
Scoliosis curve magnitude	Nov. 2014

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	Nov. 2014
Pulmonary function testing	20 years	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States