Adolescent Idiopathic Scoliosis Outcomes Database Registry

Adolescent Idiopathic Scoliosis Clinical Trial

— AIS  

Official title:

Scoliosis Outcomes Database Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01661959
• Other study ID #: 2007HSGAIS
• Status: Enrolling by invitation
• Start date: January 2005
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Setting Scoliosis Straight Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

1. 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.

2. 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).

3. 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.

4. The fourth aim is to evaluate the long-term outcomes of surgical intervention in this patient population.

5. 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.

6. 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.

7. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Setting Scoliosis Straight Foundation	DePuy Spine, NuVasive

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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

External Links

•   Harms Study Group