Adolescent Idiopathic Scoliosis Outcomes Database Registry (AIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01661959|
Recruitment Status : Enrolling by invitation
First Posted : August 10, 2012
Last Update Posted : October 30, 2019
|Condition or disease|
|Adolescent Idiopathic Scoliosis|
- The first aim of this Database Registry is to maintain a prospective multicenter series of patients treated surgically for adolescent idiopathic scoliosis. Patients from multiple scoliosis centers around the U.S., as well as a center in Germany, will be enrolled with comprehensive analysis of the curve pattern being treated, as well as the type of surgery performed. The outcome of each surgical treatment will be analyzed. This will allow the frequency of various curve types to be determined, as well as the frequency of various surgical approaches utilized for each curve pattern.
- The second aim is to determine if operative outcomes vary based on the surgical approach utilized in scoliosis correction. In this analysis, it is anticipated that specific approaches can be identified to be most appropriate for given scoliotic curve patterns. In addition, the variations within individual curve patterns will be analyzed, as will specific variations in the surgical approach (e.g., distal level of instrumentation, hooks versus screws, hook patterns, etc).
- The third aim is to develop an algorithm to guide surgical decision making based on a scoliosis curve classification scheme that will allow the surgeon to provide the best overall outcome (radiographic, functional, cosmetic) for a given patient with idiopathic scoliosis.
- The fourth aim is to evaluate the long-term outcomes of surgical intervention in this patient population.
- The fifth aim is to maintain a prospective multi-center series of patients with idiopathic scoliosis who have not undergone surgical correction of their deformity. The long-term outcome of this patient population will be compared with the surgical patient population.
- The sixth aim is to develop a guide to help clinicians make a decision for optimal surgical treatment of AIS curves based on patient-specific 3D information.
- Factors that may influence intra and post-operative course will also be evaluated. Of particular interest are patient specific factors (curve size, pre op characteristics such as blood work and PFT testing) and their influence on intra-operative blood loss.
|Study Type :||Observational|
|Actual Enrollment :||4121 participants|
|Official Title:||Scoliosis Outcomes Database Registry|
|Study Start Date :||January 2005|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
- Change in radiographic outcome for surgical treatment of idiopathic scoliosis. [ Time Frame: 25 years ]Patients are followed up to 25 years post-op.
- Change in clinical outcomes for surgical treatment of idiopathic scoliosis. [ Time Frame: 25 years ]Patients are followed up to 25 years post-op
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661959
|United States, California|
|Rady Children's Hospital|
|San Diego, California, United States, 92123|
|United States, Delaware|
|Nemours Children's Clinic|
|Wilmington, Delaware, United States, 19803|
|United States, Florida|
|Miami Children's Hospital|
|Miami, Florida, United States, 33155|
|United States, Maryland|
|John's Hopkins Medical Institute|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Washington Univ., St. Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Camden, New Jersey, United States, 08103|
|United States, New York|
|New York, New York, United States, 10017|
|United States, Ohio|
|Cincinnati Children's Hospital, Cincinnati, OH|
|Cincinnati, Ohio, United States, 45229|
|Cincinnati Children's Hospital|
|Cincinnati, Ohio, United States, 45229|
|United States, Pennsylvania|
|Childrens Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Shriners Hospital for Children|
|Philadelphia, Pennsylvania, United States, 19140|
|CHU Saint-Justine Hospital|
|British Columbia Children's Hospital|
|Principal Investigator:||Peter O Newton, MD||Rady Children's Hospital San Deigo|