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

• Conditions: Infection
• Interventions: Device: Microbiological analysis of retained VEPTR Implants

• Registration Number: NCT01085669
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief 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.

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-03
• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-11
• Last Update Submitted: 2010-03-11
• Study First Posted: 2010-03-12
• Last Update Posted: 2010-03-12
• Primary Completion: 2011-12
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VEPTR patients	Microbiological analysis of retained VEPTR Implants	Children treated with VEPTR Implants for severe spinal or thoracic deformities

Primary Outcome Measures

Name	Time	Method
Infection rate of VEPTR Implants	two years

Trial Locations

Locations (1)

Orthopaedic Department, University Children´s Hospital Basel; 🇨🇭 Basel, Switzerland