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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01085669
• Other study ID #: EKBB 304/09
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2010
• Last updated: March 11, 2010
• Start date: September 2009
• Est. completion date: May 2012

Study information

• Verified date: March 2010
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Christian Plaass, MD
• Phone: +49 152 29098211
• Email: Christian[@]Plaass.info
• Is FDA regulated: No
• Health authority: Switzerland: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 30 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Orthopaedic Department, University Children´s Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection rate of VEPTR Implants		two years	No