Status:
COMPLETED
Vertical Expandable Prosthetic Titanium Rib (VEPTR) for Thoracic Insufficiency Syndrome
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Thoracic Insufficiency Syndrome (TIS)
Eligibility:
All Genders
6-17 years
Brief Summary
The hypothesis of the study is that individuals with poor pulmonary function secondary to TIS will benefit from expansion thoracoplasty. The investigators specific aims are to: 1. Record pulmonary fu...
Detailed Description
Study procedures 1. Patient Identification \& Enrollment Patients meeting the inclusion criteria will be invited to enroll in the study as described above. 2. Serial clinical observation Patients...
Eligibility Criteria
Inclusion
- Pediatric patients, age range from 6 months - 17 years with thoracic insufficiency syndrome (TIS) will be considered for inclusion. Categories of TIS include:
- Flail chest syndrome
- Constrictive chest wall syndrome (rib fusions and scoliosis)
- Hypoplastic thorax syndrome (Jeune's syndrome, achondroplasia, Jarcho-levin syndrome, Ellis van Creveld syndrome)
- Progressive scoliosis/kyphosis of congenital, neurogenic, or idiopathic origin without rib anomaly
- Early onset scoliosis without rib anomaly at high risk for progression
Exclusion
- Failure to meet inclusion criteria.
Key Trial Info
Start Date :
November 11 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02241954
Start Date
November 11 2010
End Date
February 28 2020
Last Update
May 12 2020
Active Locations (1)
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1
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232