Adolescent Idiopathic Scoliosis Clinical Trial
— AISOfficial title:
Scoliosis Outcomes Database Registry
Verified date | November 2023 |
Source | Setting Scoliosis Straight Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 10000 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 21 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | CHU Saint-Justine Hospital | Montreal | |
Canada | British Columbia Children's Hospital | Vancouver | |
United States | John's Hopkins Medical Institute | Baltimore | Maryland |
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | University Physicians | Camden | New Jersey |
United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
United States | Cincinnati Children's Hospital, Cincinnati, OH | Cincinnati | Ohio |
United States | Miami Children's Hospital | Miami | Florida |
United States | Scoliosis Associates | New York | New York |
United States | Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Shriners Hospital for Children | Philadelphia | Pennsylvania |
United States | Washington Univ., St. Louis | Saint Louis | Missouri |
United States | Rady Children's Hospital | San Diego | California |
United States | Nemours Children's Clinic | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
Setting Scoliosis Straight Foundation | DePuy Spine, NuVasive |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in radiographic outcome for surgical treatment of idiopathic scoliosis. | Patients are followed up to 25 years post-op. | 25 years | |
Secondary | Change in clinical outcomes for surgical treatment of idiopathic scoliosis. | Patients are followed up to 25 years post-op | 25 years |
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