Adolescent Idiopathic Scoliosis Outcomes Database Registry (AIS)

• ClinicalTrials.gov Identifier: NCT01661959
• Recruitment Status: Enrolling by invitation
• First Posted: August 10, 2012
• Last Update Posted: April 28, 2022
• Sponsor: Setting Scoliosis Straight Foundation
• Collaborators: DePuy Spine; NuVasive
• Information provided by (Responsible Party): Setting Scoliosis Straight Foundation

Tracking Information

• First Submitted Date: July 10, 2012
• First Posted Date: August 10, 2012
• Last Update Posted Date: April 28, 2022
• Study Start Date: January 2005
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 7, 2012)

Change in radiographic outcome for surgical treatment of idiopathic scoliosis. [ Time Frame: 25 years ]

Patients are followed up to 25 years post-op.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 7, 2012)

Change in clinical outcomes for surgical treatment of idiopathic scoliosis. [ Time Frame: 25 years ]

Patients are followed up to 25 years post-op

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adolescent Idiopathic Scoliosis Outcomes Database Registry
• Official Title: Scoliosis Outcomes Database Registry
• Brief 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.

Detailed 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.

• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study.
• Condition: Adolescent Idiopathic Scoliosis
• Intervention: Not Provided

Study Groups/Cohorts

• Non-Operative
• Operative

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: April 26, 2022): 10000
• Original Actual Enrollment (submitted: August 7, 2012): 3519
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 21 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States
• Removed Location Countries: Germany

Administrative Information

• NCT Number: NCT01661959
• Other Study ID Numbers: 2007HSGAIS
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Setting Scoliosis Straight Foundation
• Original Responsible Party: Same as current
• Current Study Sponsor: Setting Scoliosis Straight Foundation
• Original Study Sponsor: Same as current

Collaborators

• DePuy Spine
• NuVasive

Investigators

• Principal Investigator: Peter O Newton, MD; Rady Children's Hospital San Deigo

• PRS Account: Setting Scoliosis Straight Foundation
• Verification Date: April 2022