A Study To Establish An Adolescent Idiopathic Scoliosis Outcomes Database Registry
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-001728
NCT ID: NCT01661959
Sponsor Protocol Number: 2007HSGAIS
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Annalise Larson, M.D. |
Closed-enrolling by invitation |
|
More information
Publications
Publications are currently not available