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OpenTrials
Completed

NCT Number: NCT01760434

Long-Term Outcome Following the Treatment of Pediatric Scoliosis

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

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Key information

Age range

30 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Long-term outcomes

Other

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.

Primary outcomes

  1. 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

  2. Scoliosis curve magnitude

    Time frame: Nov. 2014

Secondary outcomes

  1. 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.

  2. Health-related quality of life

    Time frame: Nov. 2014

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Scoliosis Research Society

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 4, 2013
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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