A Study to Establish An Adolescent Idiopathic Scoliosis Outcomes Database Registry

Overview

About this study

The purpose of this study is to analyze the long-term outcomes of surgical treatment of idiopathic scoliosis of all curve patterns treated by either anterior or posterior procedures. In addition, to analyze the long-term outcomes of non-operative idiopathic scoliosis.

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 - Database Registry: 

  • Patients aged  ≤ 26 years who present with a curve large enough that a definitive fusion for idiopathic scoliosis would be considered an option.
  • Male or female.
  • Diagnosis of idiopathic scoliosis for which definitive fusion surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement.
  • Curve cobb of any magnitude – operative range.
  • Spina bifida Oculta is permitted.
  • Spondylolisthesis and Spondylolysis are permitted, as long as non-operative.
  • Non-operative idiopathic scoliosis patients:
    • Aged  ≤ 26 years, male or female, curve cobb of ≥40º, whom elected not to proceed with surgery; or
    • Aged  ≤ 26 years, male or female, Curve cobb ≥ 30º and approaching skeletally mature (defined as Age:  girls > 14 yrs; Boys > 16 yrs and Risser of ≥ 4 or sanders ≥7).

Execlusion Criteria - Database Registry:

  • Prior spinal surgery.
  • MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation).
  • Neuromuscular or other serious co-morbidities.
  • Thoracogenic or cardiogenic scoliosis.
  • Associated syndrome or developmental delay.
  • 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.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Smitha Mathew M.B.B.S.

(507) 538-3560

Mathew.Smitha@mayo.edu

More information

Publications

Publications are currently not available