Vertical Expandable Prosthetic Titanium Rib (VEPTR) for Thoracic Insufficiency Syndrome

Completed

Conditions studied: Thoracic Insufficiency Syndrome (TIS)

In brief

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 function and thoracic volume of TIS patients at enrollment and with serial observation 2. Offer expansion thoracoplasty therapy to TIS patients with 1. poor pulmonary function at enrollment 2. progressive decline in pulmonary function 3. progressive chest wall and/or spinal deformity 4. lack of appropriate increase in thoracic volume during growth 3. Document efficacy of expansion thoracoplasty for TIS patients

Key facts

Study ID

NCT02241954

Run by

Vanderbilt University Medical Center

People needed

7

Starts

2010-11-11

Expected to finish

2020-02-28

Last updated by the study team

2020-05-12

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Failure to meet inclusion criteria.

Where it is running

• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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