VEPTR Study

Vertical Expandable Prosthetic Titanium Rib for the Treatment of Thoracic Insufficiency Syndrome

Protocol Description

This study monitors the application of the Vertical Expandable Prosthetic Titanium Rib (VEPTR), a device with a humanitarian use exemption by the U.S. Food and Drug Administration, for treatment of Thoracic Insufficiency Syndrome (TIS) in skeletally immature patients. TIS is the inability of the chest to support normal breathing or lung growth. Expansion of the rib cage with the VEPTR, also known as the “titanium rib,” is a relatively new surgical method aimed at improving deformities and pulmonary function in affected children. Through this technique, a curved metal rod placed vertically between the ribs keeps the chest wall expanding, allowing the lungs to fill with enough air to breathe and to further develop.

Eligibility Criteria

Infants and children of both genders will be evaluated by an orthopaedic surgeon, pediatric surgeon and pulmonary specialist to determine eligibility status for this procedure.
Boys: Birth to 10 years
Girls: Birth to 10 years

Requirements

After a thorough evaluation, participants will undergo surgical procedure inserting the device that will make the rib cage grow longer and larger as the child develops. The child will need expansion or exchange operations to allow for his/her growth every 4 to 6 months. Additional spine X-rays, lab work and pulmonary function tests will be administered throughout the length of participation.
Visits: Multiple
Duration: Until skeletal maturity

Status: Open for Enrollment

Source(s) of Support

Synthes North America

Contact Information

To get started, please contact:
Joanne A. Londino, RN, BSN
412-692-5772