NCT01085669

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

Infection Rate of VEPTR-Implants in Children With Severe Spinal and Thoracic Deformities

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Infection

Interventions

Type	Name	Description
DEVICE	Microbiological analysis of retained VEPTR Implants	Implants have to be adapted every half a year, the retained implants during revision are analysed for biological colonization.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-12-01
• Completion: 2012-05-01
• First posted: 2010-03-12
• Last updated: 2010-03-12

Locations

1 site across 1 country: Switzerland