Adolescent Idiopathic Scoliosis Outcomes Database Registry

Status unconfirmed

Conditions studied: Adolescent Idiopathic Scoliosis

In brief

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.

Key facts

Study ID

NCT01661959

Run by

Setting Scoliosis Straight Foundation

People needed

10000

Starts

2005-01-01

Expected to finish

2025-12-01

Last updated by the study team

2023-11-21

Who can join

Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged ≥ 10 and ≤ 21 years at time of enrollment,
• male or female,
• diagnosis of idiopathic scoliosis for which 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 ≥ 10 and ≤ 21 years, male or female, curve cobb of ≥ 40º, for whom surgery has been offered and the patient has elected not to proceed with surgery.
• OR
• OPTIONAL BY SITE: aged ≥ 10 and ≤ 21 years, male or female, Curve cobb ≥ 30º and skeletally mature (with maturity defined as Age: girls > 14 yrs; Boys > 16 yrs and Risser of ≥ 4 Plus one of the following: Girls 2+ yrs post menarchal, boys shaving regularly, no height change in at least 6 months.

You may not qualify if…

• 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

Where it is running

• Rady Children's Hospital — San Diego, California, United States
• Nemours Children's Clinic — Wilmington, Delaware, United States
• Miami Children's Hospital — Miami, Florida, United States
• John's Hopkins Medical Institute — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Washington Univ., St. Louis — St Louis, Missouri, United States
• University Physicians — Camden, New Jersey, United States
• Scoliosis Associates — New York, New York, United States
• Cincinnati Children's Hospital, Cincinnati, OH — Cincinnati, Ohio, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Childrens Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Shriners Hospital for Children — Philadelphia, Pennsylvania, United States
• CHU Saint-Justine Hospital — Montreal, Canada
• British Columbia Children's Hospital — Vancouver, Canada

Full record on ClinicalTrials.gov

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