Clinical trial NCT01760434: Long-Term Outcome Following the Treatment of Pediatric Scoliosis
Official title: Prospective Study: Long-Term Pulmonary Function, Health-Related Quality of Life, and Sagittal Plane Alignment Following the Treatment of Pediatric Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: scoliosis
long-term outcomes
sagittal plane
quality of life
curve progression
pulmonary function
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Scoliosis Research Society
First posted: 2013-01-04
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cobb angle and sagittal plane alignment
timeFrame: 20 years
measure: Scoliosis curve magnitude
timeFrame: Nov. 2014
Secondary outcomes:
measure: Pulmonary function testing
timeFrame: 20 years
measure: Health-related quality of life
timeFrame: Nov. 2014
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Annalise Noelle Larson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Michael J. Yaszemski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: