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

Brief Title

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

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).
    


Study Type

Observational [Patient Registry]


Primary Outcome

Clinical and Radiographic

Secondary Outcome

 Patient based outcomes

Condition

Early Onset Scoliosis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

2602

Start Date

October 2008

Completion Date

February 4, 2020

Primary Completion Date

February 4, 2020

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
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

No

Contacts

Paul D Sponseller, MD, MBA, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02299362

Organization ID

IRB-08055C


Responsible Party

Sponsor

Study Sponsor

Growing Spine Study Group

Collaborators

 Growing Spine Foundation

Study Sponsor

Paul D Sponseller, MD, MBA, Principal Investigator, Johns Hopkins Bloomberg Children's Center


Verification Date

February 2020