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

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.

Study Overview

• Status: Completed
• Conditions: Early Onset Scoliosis; Thoracic Insufficiency Syndrome; Congenital Spinal Deformities; Infantile Idiopathic Scoliosis; Neuromuscular Spinal Deformity; Syndromic Spinal Deformity

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).

• Study Type: Observational
• Enrollment (Actual): 2602

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • British Columbia Children's Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Hospital Sainte-Justine
• Egypt
  • Giza, Egypt, 12411
    • Cairo University
• Ghana
  • Pantang West
    • Accra, Pantang West, Ghana
      • FOCOS Orthopaedic Hospital
• Spain
  • Madrid, Spain, 28029
    • Hospital Unversitario La Paz
  • Sevilla, Spain, 41013
    • Hospitales Unversitarios Virgen del Rocio
• Turkey
  • Ankara, Turkey, 06450
    • HACETTEPE UNIVERSİTY
• United Kingdom
  • Birmingham, United Kingdom, B31 2AP
    • Royal Orthopaedic Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • Delaware
    • Wilmington, Delaware, United States, 19899
      • Nemours/Alfred I. duPont Hospital for Children
  • District of Columbia
    • Washington, District of Columbia, United States, 10010
      • Children's National Medical Center
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Riley Hospital for Children
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115-5724
      • Children's Hospital Boston
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • C.S. Mott Childrens Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • Rochester, New York, United States, 14642
      • University of Rochester
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
    • Cleveland, Ohio, United States, 44106
      • Rainbow Babies and Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Texas
    • Dallas, Texas, United States, 75219
      • Texas Scottish Rite Hospital for Children
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving treatment at participating study sites who are eligible and agree to participate in the study.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and Radiographic	Evaluation of long-term clinical measures such as: BMI, Pulmonary functionality, incidence of complications; and radiographic outcomes (e.g. coronal spinal curvature, sagittal profile, spinal and thoracic growth, coronal and sagittal alignment.	18 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient based outcomes	Evaluation of the effect of treatment on patients and families by use of serial early-onset scoliosis questionnaire (EOSQ-24) scores during treatment. EOSQ covers the following domains: Child's Health Related Quality of Life (16 items), Family Impact (2 items) and Satisfaction (2 items).	18 years

Collaborators and Investigators

• Sponsor: Growing Spine Study Group
• Collaborators: Growing Spine Foundation
• Investigators: Principal Investigator: Paul D Sponseller, MD, MBA, Johns Hopkins Bloomberg Children's Center

Publications and helpful links

Helpful Links

• Growing Spine Foundation webpage

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 4, 2020
• Study Completion (Actual): February 4, 2020

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Pulmonary function; EOS; Cast; Early Onset Scoliosis; Growing rods; Infantile Idiopathic Scoliosis; MCGR; Magnetically controlled growing rods; Growth friendly spine surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Congenital Abnormalities; Scoliosis
• Other Study ID Numbers: IRB-08055C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data stored in the GSSG database will also be shared with 24 sites that comprise the Children's Spine Study Group (CSSG). The collaboration between GSSG and CSSG is solely for research purposes.

Fully de-identified data from the GSSG database may be shared with key stakeholders including, but not limited to, medical device companies, professional societies, regulatory agencies, patients and surgeons to support endeavors that are aimed to improve the care of EOS patients. These data may be shared to support the following activities:

1. Filings for medical device clearance by the U.S. Food and Drug Administration (FDA)
2. Health care cost assessments
3. Future clinical research studies on EOS