Adolescent Idiopathic Scoliosis Outcomes Database Registry

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 10 Years - 21 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01661959
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Setting Scoliosis Straight Foundation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Peter O Newton, MD
Principal Investigator Affiliation Rady Children's Hospital San Deigo
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustryIndustry
Overall Status Enrolling by invitation
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Adolescent Idiopathic Scoliosis
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: Non-Operative

: Operative

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rady Children's Hospital, San Diego, California

Status

Address

Rady Children's Hospital

San Diego, California, 92123

Nemours Children's Clinic, Wilmington, Delaware

Status

Address

Nemours Children's Clinic

Wilmington, Delaware, 19803

Miami Children's Hospital, Miami, Florida

Status

Address

Miami Children's Hospital

Miami, Florida, 33155

John's Hopkins Medical Institute, Baltimore, Maryland

Status

Address

John's Hopkins Medical Institute

Baltimore, Maryland, 21287

Boston Children's Hospital, Boston, Massachusetts

Status

Address

Boston Children's Hospital

Boston, Massachusetts, 02115

Washington Univ., St. Louis, Saint Louis, Missouri

Status

Address

Washington Univ., St. Louis

Saint Louis, Missouri, 63110

University Physicians, Camden, New Jersey

Status

Address

University Physicians

Camden, New Jersey, 08103

Scoliosis Associates, New York, New York

Status

Address

Scoliosis Associates

New York, New York, 10017

Cincinnati, Ohio

Status

Address

Cincinnati Children's Hospital, Cincinnati, OH

Cincinnati, Ohio, 45229

Cincinnati Children's Hospital, Cincinnati, Ohio

Status

Address

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229

Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Shriners Hospital for Children, Philadelphia, Pennsylvania

Status

Address

Shriners Hospital for Children

Philadelphia, Pennsylvania, 19140

International Sites

CHU Saint-Justine Hospital, Montreal, Canada

Status

Address

CHU Saint-Justine Hospital

Montreal, ,

British Columbia Children's Hospital, Vancouver, Canada

Status

Address

British Columbia Children's Hospital

Vancouver, ,