Adolescent Idiopathic Scoliosis Outcomes Database Registry (AIS)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier:
NCT01661959
First received: July 10, 2012
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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
Adolescent Idiopathic Scoliosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Scoliosis Outcomes Database Registry

Resource links provided by NLM:


Further study details as provided by Setting Scoliosis Straight Foundation:

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


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


Enrollment: 4121
Study Start Date: January 2005
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-Operative
Operative

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 final 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.
  Eligibility

Ages Eligible for Study:   10 Years to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661959

Locations
United States, California
UC Davis
Sacramento, California, United States, 95616
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, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, New Jersey
University Physicians
Camden, New Jersey, United States
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
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States, 19140
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Canada
CHU Saint-Justine Hospital
Montreal, Canada
British Columbia Children's Hospital
Vancouver, Canada
Sponsors and Collaborators
Setting Scoliosis Straight Foundation
DePuy Spine
Investigators
Study Chair: Peter O Newton, MD Rady Children's Hospital San Deigo
  More Information

Additional Information:
No publications provided

Responsible Party: Setting Scoliosis Straight Foundation
ClinicalTrials.gov Identifier: NCT01661959     History of Changes
Other Study ID Numbers: 2007HSGAIS
Study First Received: July 10, 2012
Last Updated: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Setting Scoliosis Straight Foundation:
Scoliosis
Multi-center Database Registry
Spinal Deformity
Adolescent Idiopathic Scoliosis

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 22, 2014