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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

Study Description
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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.

Condition or disease
Adolescent 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 Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Scoliosis Outcomes Database Registry
Study Start Date : January 2005
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Groups and Cohorts
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Group/Cohort
Non-Operative
Operative


Outcome Measures
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Primary Outcome Measures :
  1. Change in radiographic outcome for surgical treatment of idiopathic scoliosis. [ Time Frame: 25 years ]
    Patients are followed up to 25 years post-op.


Secondary Outcome Measures :
  1. Change in clinical outcomes for surgical treatment of idiopathic scoliosis. [ Time Frame: 25 years ]
    Patients are followed up to 25 years post-op


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
University Physicians
Camden, New Jersey, United States, 08103
United States, New York
Scoliosis Associates
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
Canada
CHU Saint-Justine Hospital
Montreal, Canada
British Columbia Children's Hospital
Vancouver, Canada
Sponsors and Collaborators
Setting Scoliosis Straight Foundation
DePuy Spine
NuVasive
Investigators
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Principal Investigator: Peter O Newton, MD Rady Children's Hospital San Deigo
More Information
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Additional Information:

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Responsible Party: Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier: NCT01661959    
Other Study ID Numbers: 2007HSGAIS
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Keywords provided by Setting Scoliosis Straight Foundation:
Scoliosis
Multi-center Database Registry
Spinal Deformity
Adolescent Idiopathic Scoliosis
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases