Long-Term Outcome Following the Treatment of Pediatric Scoliosis

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Prospective Study: Long-Term Pulmonary Function, Health-Related Quality of Life, and Sagittal Plane Alignment Following the Treatment of Pediatric Scoliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760434
• Other study ID #: 12-008308
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 2015

Study information

• Verified date: March 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the long-term outcomes following operative and nonoperative treatment of childhood scoliosis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Other:
• Long-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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Scoliosis Research Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Scoliosis curve magnitude		Nov. 2014
Secondary	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.	20 years
Secondary	Health-related quality of life		Nov. 2014

External Links

•   Mayo Clinic Clinical Trials