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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01760434
Other study ID # 12-008308
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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