Long-Term Outcome Following the Treatment of Pediatric Scoliosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Mayo Clinic
Sponsor:
Collaborator:
Scoliosis Research Society
Information provided by (Responsible Party):
A. Noelle Larson, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01760434
First received: January 2, 2013
Last updated: June 2, 2014
Last verified: November 2013
  Purpose

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


Condition Intervention
Adolescent Idiopathic Scoliosis
Other: Long-term outcomes

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study: Long-Term Pulmonary Function, Health-Related Quality of Life, and Sagittal Plane Alignment Following the Treatment of Pediatric Scoliosis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Cobb angle and sagittal plane alignment [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary function testing [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: January 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Long-Term Outcomes
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.

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760434

Contacts
Contact: Annalise N Larson, MD (507) 284-2995 larson.noelle@mayo.edu
Contact: Vickie Treder, LPN 507-538-3561

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Annalise N Larson, MD    507-284-3660    larson.noelle@mayo.edu   
Contact: Vickie Treder, LPN    507-538-3561      
Principal Investigator: Annalise Noelle Larson, MD         
Principal Investigator: Michael J. Yaszemski, MD, PhD         
Sponsors and Collaborators
Mayo Clinic
Scoliosis Research Society
Investigators
Principal Investigator: Annalise Noelle Larson, MD Mayo Clinic
Principal Investigator: Michael J. Yaszemski, MD, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: A. Noelle Larson, Co-Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01760434     History of Changes
Other Study ID Numbers: 12-008308
Study First Received: January 2, 2013
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
scoliosis
long-term outcomes
sagittal plane
quality of life
curve progression
pulmonary function

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 14, 2014