A Study to Evaluate a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis

Overview

About this study

The purpose of this study is to characterize the risk of scoliosis progression based on local three-dimensional vertebral and pelvic measurements present on initial evaluation. The proposed new study aims at refining and testing the external validity of this model in a larger cohort. The next step towards using the new model in the clinical setting is to redesign the model and to externally validate the model by measuring the agreement between the new method and the traditional Cobb angle at maturity in a larger multicenter study.  The ultimate goal of this research project will be to validate this new predictive model and finally transfer this new predictive tool in the hands of clinicians treating AIS.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Idiopathic Scoliosis (as diagnosed by the surgeon).
  • Patients above 10 years old at the time of recruitment.
  • Spina bifida occulta with no neurological signs and otherwise normal.
  • Curves ranging between 11º and 40º of Cobb angle measurement and - Risser 0 or 1, as measured on a standing postero-anterior digital radiograph of the spine. 
  • All single thoracic, thoraco-lumbar, lumbar, double major and triple major curves will be included in the study.

Exclusion Criteria:

  • Previous thoracic, pelvis or spine surgery as they may be co-factors in scoliosis initiation.
  • Congenital scoliosis, - MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation).
  • Syndromic scoliosis (associated with Marfan's or other genetic syndromes).
  • Neuromuscular scoliosis.
  • Developmental delay. 
  • Spinal asymmetry. 
  • Symptomatic spondylolisthesis. 
  • Leg length discrepancy longer than 1 cm. 
  • Unable or unwilling to firmly commit to returning for required follow-up visits.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Annalise Larson, M.D.

Open for enrollment

Contact information:

Smitha Mathew M.B.B.S.

(507)538-3560

Mathew.Smitha@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

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Supplemental Study Information

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