Early Onset ScoliosisGSSGNCT02299362
The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study
An observational study of Early Onset Scoliosis and Congenital Spinal Deformities, run by Growing Spine Study Group at 27 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Early Onset Scoliosis, Congenital Spinal Deformities, Infantile Idiopathic Scoliosis
- How many people
- 2,602 participants
- Where
- 27 sitesin 7 countries
- Study dates
- Oct 2008to 4 Feb 2020
- How long will I take part?
- 18 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients receiving treatment at participating study sites who are eligible and agree to participate in the study.
Who may be able to join
- 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
Who cannot join
- Cervical spine anomalies alone will not be included
- Patient/family is unwilling to participate in the study
Trial locations and contacts
27 sites in 7 countries.
27 sites in 7 countries
United States19 sites
C.S. Mott Childrens Hospital
Ann Arbor, Michigan, 48109
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Children's Hospital Boston
Boston, Massachusetts, 02115-5724
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Texas Scottish Rite Hospital for Children
Dallas, Texas, 75219
University of Florida
Gainesville, Florida, 32611
Texas Children's Hospital
Houston, Texas, 77030
Indiana University Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Children's Hospital Los Angeles
Los Angeles, California, 90027
Hospital for Special Surgery
New York, New York, 10021
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Rochester
Rochester, New York, 14642
Rady Children's Hospital
San Diego, California, 92123
Washington University
St Louis, Missouri, 63110
Children's National Medical Center
Washington D.C., District of Columbia, 10010
Nemours/Alfred I. Dupont Hospital for Children
Wilmington, Delaware, 19899
Canada2 sites
Hospital Sainte-Justine
Montreal, Quebec, H3T 1C5
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Spain2 sites
Hospital Unversitario La Paz
Madrid, 28029
Hospitales Unversitarios Virgen del Rocio
Seville, 41013
About this study
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.
Read the 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:
- How do clinical parameters (e.g. height, weight, pulmonary function, incidence of complications) differ between:
- Age groups
- Etiologic groups
- Treatment types including operative and non-operative methods
- Patients who receive definitive spinal fusion versus those who do not
- How do radiographic parameters (e.g. curve size, spinal height, thoracic dimensions, sagittal profile, pelvic parameters, spinal balance) differ between:
- Age groups
- Etiologic groups
- Treatment types including operative and non-operative methods
- Patients who receive definitive spinal fusion versus those who do not
- How does health-related quality of life (HRQOL), using the EOSQ-24 outcomes tool, differ between:
- Age groups
- Etiologic groups
- Treatment types including operative and non-operative methods
- Patients who receive definitive spinal fusion versus those who do not
- What demographic, clinical, radiographic, and surgical factors contribute to the incidence of complications?
- For patients with a particular diagnosis, age and/or treatment type, what are the clinical, radiographic and HRQOL changes before and after treatment?
- 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
- Keywords
- Early Onset Scoliosis, EOS, Pulmonary function, Infantile Idiopathic Scoliosis, MCGR, Magnetically controlled growing rods, Growing rods, Growth friendly spine surgery, Cast
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 years
Secondary outcomes (1)
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).
Measured: 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startOct 2008
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Onset ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,602 participants (actual)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- Growing Spine Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Growing Spine Foundation
- Responsible party
- Sponsor
- Investigators
- Paul D Sponseller, MD, MBA, Principal investigator, Johns Hopkins Bloomberg Children's Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299362
- Sponsor's protocol ID
- IRB-08055C
- Acronym
- GSSG
- Status last verified
- Feb 2020
- First submitted
- 18 Nov 2014
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study
- ClinicalTrials.gov ID
- NCT02299362
- Acronym / sponsor ID
- GSSG / IRB-08055C
- Conditions
- Early Onset Scoliosis, Congenital Spinal Deformities, Infantile Idiopathic Scoliosis, Neuromuscular Spinal Deformity, Syndromic Spinal Deformity, Thoracic Insufficiency Syndrome
- Keywords
- Early Onset Scoliosis, EOS, Pulmonary function, Infantile Idiopathic Scoliosis, MCGR, Magnetically controlled growing rods, Growing rods, Growth friendly spine surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,602 participants (actual)
- Lead sponsor
- Growing Spine Study GroupUniversity, hospital or other
- Collaborators
- Growing Spine Foundation
- Study start
- Oct 2008
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How do clinical parameters (e.g. height, weight, pulmonary function, incidence of complications) differ between:
- Age groups
- Etiologic groups
- Treatment types including operative and non-operative methods
- Patients who receive definitive spinal fusion versus those who do not
- How do radiographic parameters (e.g. curve size, spinal height, thoracic dimensions, sagittal profile, pelvic parameters, spinal balance) differ between:
- Age groups
- Etiologic groups
- Treatment types including operative and non-operative methods
- Patients who receive definitive spinal fusion versus those who do not
- How does health-related quality of life (HRQOL), using the EOSQ-24 outcomes tool, differ between:
- Age groups
- Etiologic groups
- Treatment types including operative and non-operative methods
- Patients who receive definitive spinal fusion versus those who do not
- What demographic, clinical, radiographic, and surgical factors contribute to the incidence of complications?
- For patients with a particular diagnosis, age and/or treatment type, what are the clinical, radiographic and HRQOL changes before and after treatment?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Years
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients receiving treatment at participating study sites who are eligible and agree to participate in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Cervical spine anomalies alone will not be included
- Patient/family is unwilling to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical and Radiographic
Time frame: 18 years
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.
1 secondary outcome
Patient based outcomes
Time frame: 18 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Growing Spine Foundation webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
Related trials for Early Onset Scoliosis
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Management of Early Onset Scoliosis by Active Apex Correction Technique
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Early Onset Scoliosis (EOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul D Sponseller, MD, MBA principal investigator
Johns Hopkins Bloomberg Children's Center
27 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Onset Scoliosis and Congenital Spinal Deformities, run by Growing Spine Study Group at 27 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Canada, Spain, Egypt, Ghana and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and Radiographic (time frame: 18 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.