The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study

NCT ID: NCT02299362

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2602 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2020-02-04

Brief Summary

The purpose of this study is to examine the treatment, both surgical and non-surgical, of patients with any form of early onset scoliosis. Such treatment may include the use of growth friendly devices that are surgically or magnetically lengthened; or the use of serial body casting or bracing, or observation. Outcomes examined will be what can be seen physically on the patient and on x-ray, as well as parent perception of how the treatment effects their child with the use of a health-related quality of life (HRQOL) questionnaire.

Detailed Description

This multi-center study will evaluate the long-term clinical and radiographic outcomes of Early Onset Scoliosis (EOS) and other Early Onset Spinal and Chest Wall Deformities in a large population of patients.

The study will attempt to answer the following clinical questions:

1. How do clinical parameters (e.g. height, weight, pulmonary function, incidence of complications) differ between:

1. Age groups

2. Etiologic groups

3. Treatment types including operative and non-operative methods

4. Patients who receive definitive spinal fusion versus those who do not

2. How do radiographic parameters (e.g. curve size, spinal height, thoracic dimensions, sagittal profile, pelvic parameters, spinal balance) differ between:

1. Age groups

2. Etiologic groups

3. Treatment types including operative and non-operative methods

4. Patients who receive definitive spinal fusion versus those who do not

3. How does health-related quality of life (HRQOL), using the EOSQ-24 outcomes tool, differ between:

1. Age groups

2. Etiologic groups

3. Treatment types including operative and non-operative methods

4. Patients who receive definitive spinal fusion versus those who do not

4. What demographic, clinical, radiographic, and surgical factors contribute to the incidence of complications?

5. For patients with a particular diagnosis, age and/or treatment type, what are the clinical, radiographic and HRQOL changes before and after treatment?

6. What are the mechanisms that cause rod breakage in growing rod constructs? (This study question is a collaborative research study with the U.S. Food and Drug Administration).

Conditions

Early Onset Scoliosis; Congenital Spinal Deformities; Infantile Idiopathic Scoliosis; Neuromuscular Spinal Deformity; Syndromic Spinal Deformity; Thoracic Insufficiency Syndrome

Study Design

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

Eligibility Criteria

Inclusion Criteria

• Patients of any age and any diagnosis who undergo a growth-friendly surgical procedure, including but not limited to growing rods, VEPTR, Shilla, hybrid constructs, spinal tethering and staples
• Patients of any age and any diagnosis who undergo casting
• Patients of any diagnosis 10 years of age and younger who undergo spinal fusion of the thoracic and/or lumbar spine
• Patients of any diagnosis under 6 years of age with scoliosis curves of the thoracic and/or lumbar spine measuring > 25 degrees. Observed and braced patients included

Exclusion Criteria

• Cervical spine anomalies alone will not be included
• Patient/family is unwilling to participate in the study

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Growing Spine Foundation

UNKNOWN

Sponsor Role: collaborator

Growing Spine Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul D Sponseller, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg Children's Center

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Rady Children's Hospital

San Diego, California, United States

Nemours/Alfred I. Dupont Hospital for Children

Wilmington, Delaware, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

University of Florida

Gainesville, Florida, United States

Indiana University Riley Hospital for Children

Indianapolis, Indiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Children's Hospital Boston

Boston, Massachusetts, United States

C.S. Mott Childrens Hospital

Ann Arbor, Michigan, United States

Children's Mercy Kansas City

Kansas City, Missouri, United States

Washington University

St Louis, Missouri, United States

Hospital for Special Surgery

New York, New York, United States

University of Rochester

Rochester, New York, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Scottish Rite Hospital for Children

Dallas, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Hospital Sainte-Justine

Montreal, Quebec, Canada

Cairo University

Giza, , Egypt

FOCOS Orthopaedic Hospital

Accra, Pantang West, Ghana

Hospital Unversitario La Paz

Madrid, , Spain

Hospitales Unversitarios Virgen del Rocio

Seville, , Spain

Hacettepe University

Ankara, , Turkey (Türkiye)

Royal Orthopaedic Hospital

Birmingham, , United Kingdom

Countries

United States; Canada; Egypt; Ghana; Spain; Turkey (Türkiye); United Kingdom

Related Links

https://www.growingspine.org/research

Growing Spine Foundation webpage

Other Identifiers

IRB-08055C

Identifier Type: -

Identifier Source: org_study_id