Infection Rate of Vertical Expandable Prosthetic Titanium Rib Implants (VEPTR)

Vaud University Hospital Center

Status: Unknown

Conditions: Infection

Treatments: Device: Microbiological analysis of retained VEPTR Implants

Study type: Observational

Funder types: Other

Identifiers

NCT01085669

EKBB 304/09

Details and patient eligibility

About

The study is conducted to analyse the infection rate in children treated with VEPTR-Implants for severe spine or thoracic deformities.

Full description

Spinal and thoracic deformities in children can be treated with vertical expandable prosthetic titanium ribs (VEPTR©, Synthes GmbH®) to stimulate thoracic and spinal growth. With these implants children's symptoms and conditions can be slowed, halted or even reversed. Because of the dynamic character of the deformity and the growth of the children, the implants have to be lengthened about every half a year. With each operation there is a small risk of infection, which might increase with number of previous surgeries. Implant associated infections are often not clinical apparent and only found in microbiological analysis. To objectify the infection rate, identify potential precursors of infections and the relevance of asymptomatic infections in children with these implants a prospective study is conducted.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients admitted at the University Children's Hospital Basel in whom a VEPTR©-implant or parts of it will be removed.

Exclusion criteria

• obvious contamination of an explanted component occurred in the operating room.

Trial design

50 participants in 1 patient group

VEPTR patients

Description:

Children treated with VEPTR Implants for severe spinal or thoracic deformities

Treatment:

Device: Microbiological analysis of retained VEPTR Implants