CompletedNot Applicable

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

United States2,602 participantsStarted 2008-10

Plain-language 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.

Who can participate

Age range1 Day – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinical and Radiographic

Timeframe: 18 years

Trial details

NCT IDNCT02299362

SponsorGrowing Spine Study Group

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-02-04

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