Adolescent Idiopathic Scoliosis Outcomes Database Registry

NCT ID: NCT01661959

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2025-12-31

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.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-Operative

No interventions assigned to this group

Operative

No interventions assigned to this group

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Spine

INDUSTRY

Sponsor Role: collaborator

NuVasive

INDUSTRY

Sponsor Role: collaborator

Setting Scoliosis Straight Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter O Newton, MD

Role: PRINCIPAL_INVESTIGATOR

Rady Children's Hospital San Deigo

Locations

Rady Children's Hospital

San Diego, California, United States

Nemours Children's Clinic

Wilmington, Delaware, United States

Miami Children's Hospital

Miami, Florida, United States

John's Hopkins Medical Institute

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Washington Univ., St. Louis

St Louis, Missouri, United States

University Physicians

Camden, New Jersey, United States

Scoliosis Associates

New York, New York, United States

Cincinnati Children's Hospital, Cincinnati, OH

Cincinnati, Ohio, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Shriners Hospital for Children

Philadelphia, Pennsylvania, United States

CHU Saint-Justine Hospital

Montreal, , Canada

British Columbia Children's Hospital

Vancouver, , Canada

Countries

United States; Canada

Related Links

http://www.hsg.settingscoliosisstraight.org

Harms Study Group

Other Identifiers

2007HSGAIS

Identifier Type: -

Identifier Source: org_study_id