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Adolescent Idiopathic Scoliosis Outcomes Database Registry (AIS)

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ClinicalTrials.gov Identifier: NCT01661959
Recruitment Status : Enrolling by invitation
First Posted : August 10, 2012
Last Update Posted : April 28, 2022
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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