Long-Term Outcome Following the Treatment of Pediatric Scoliosis
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|ClinicalTrials.gov Identifier: NCT01760434|
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Idiopathic Scoliosis||Other: Long-term outcomes||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Study: Long-Term Pulmonary Function, Health-Related Quality of Life, and Sagittal Plane Alignment Following the Treatment of Pediatric Scoliosis|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
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.
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.
- Cobb angle and sagittal plane alignment [ Time Frame: 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 [ Time Frame: Nov. 2014 ]
- Pulmonary function testing [ Time Frame: 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.
- Health-related quality of life [ Time Frame: Nov. 2014 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760434
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Annalise Noelle Larson, MD||Mayo Clinic|
|Principal Investigator:||Michael J. Yaszemski, MD, PhD||Mayo Clinic|