Long-Term Outcome Following the Treatment of Pediatric Scoliosis

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Mayo Clinic

Status

Completed

Conditions

Adolescent Idiopathic Scoliosis

Treatments

Other: Long-term outcomes

Study type

Interventional

Funder types

Other

Identifiers

NCT01760434
12-008308

Details and patient eligibility

About

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

Full 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.

Enrollment

66 patients

Sex

All

Ages

30 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

66 participants in 1 patient group

Long-Term Outcomes
Other group
Description:
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.
Treatment:
Other: Long-term outcomes

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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