Clinical trial NCT02299362: The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study
Official title: The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Growing Spine Study Group
Sponsor class: OTHER
Collaborators: name: Growing Spine Foundation
First posted: 2014-11-24
Enrollment: 2602
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving treatment at participating study sites who are eligible and agree to participate in the study.

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).

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

Primary outcomes:
measure: Clinical and Radiographic
timeFrame: 18 years
Secondary outcomes:
measure: Patient based outcomes
timeFrame: 18 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Wilmington
country: United States
facility: Nemours/Alfred I. Dupont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Riley Hospital for Children
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Ann Arbor
country: United States
facility: C.S. Mott Childrens Hospital
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Scottish Rite Hospital for Children
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Montreal
country: Canada
facility: Hospital Sainte-Justine
state: Quebec
city: Giza
country: Egypt
facility: Cairo University
city: Accra
country: Ghana
facility: FOCOS Orthopaedic Hospital
state: Pantang West
city: Madrid
country: Spain
facility: Hospital Unversitario La Paz
city: Sevilla
country: Spain
facility: Hospitales Unversitarios Virgen del Rocio
city: Ankara
country: Turkey
facility: Hacettepe University
city: Birmingham
country: United Kingdom
facility: Royal Orthopaedic Hospital
Study officials:
affiliation: Johns Hopkins Bloomberg Children's Center
name: Paul D Sponseller, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: