Infantile Clinical Trial
Official title:
VEPTR Implantation to Treat Children With Early Onset Scoliosis Without Rib Abnormalities: a Prospective Multicenter Study
Primary Objective: To evaluate the use of unilateral or bilateral VEPTR devices, with or without expansion thoracoplasty, for preventing further progression of the Cobb angle, allowing for spinal growth and improving pulmonary function in the treatment of children with progressive scoliosis without rib abnormalities.
Number of Patients Planned: A total of 250 patients requiring treatment with the VEPTR
device and meeting the inclusion/exclusion criteria will be enrolled in the study. All
patients enrolled in this study will receive the VEPTR device.
Duration of Follow-up: Patients will be clinically followed post-surgery throughout the
course of the patient's treatment. Follow-up appointments will be scheduled at 1, 6, and 12
months post-surgery and every year thereafter until 5 years after the index procedure, then
every 2 years until the final planned procedure, or the completion or spinal growth
(typically about 2 years after menarche in girls, or the equivalent in boys), whichever
occurs first. Other patient visits may occur as deemed necessary.
General Design and Methodology: This is a prospective, multi-center, clinical study to
evaluate the use of VEPTR devices for preventing further progression of the Cobb angle, a
measure of the curvature of the spine, determined from measurements made on radiographs,
allowing for spinal growth and improving pulmonary function in the treatment of children
with progressive scoliosis without rib abnormalities. Unilateral vs. Bilateral, and use of
an opening wedge thoracostomy, are at the discretion of the surgeon. The treatment would be
used regardless of the study, therefore it is routine care. The primary study hypothesis is
that, in regard to key clinical and radiographic outcomes, the success rate of the VEPTR
device is at least 90%. A secondary study hypothesis is that in regards to key pulmonary
outcomes (improvement in pulmonary function tests and increase in lung volume as measured by
CT scans), the success rate of the VEPTR device is at least 90% (see Primary Study Endpoints
below). Details of the patient outcomes and the study hypothesis are given below. With
correction for 10% attrition, 250 patients split between the participating institutions will
be enrolled.
Primary Study Endpoints: The primary endpoint will be based on the findings up to and
including the last scheduled patient follow-up visit. An individual patient's treatment will
be considered successful only if each of the following criteria are met:
- The patient's Cobb angle at the final surgery is less than or equal to the patient's
pre-operative Cobb angle and
- The patient's trunk height or spinal length at final surgery is greater than or equal
to the patient's immediate post-operative trunk height or spinal length
;
Observational Model: Cohort, Time Perspective: Prospective
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