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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01085669
Enrollment
50
Registered
2010-03-12
Start date
2009-09-30
Completion date
2012-05-31
Last updated
2010-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

Infection rate of VEPTR-Implants, VEPTR. Vertical Expandable, Prosthetic Titanium Rib

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.

Interventions

DEVICEMicrobiological analysis of retained VEPTR Implants

Implants have to be adapted every half a year, the retained implants during revision are analysed for biological colonization.

Sponsors

University Children's Hospital Basel
CollaboratorOTHER
Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 30 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Infection rate of VEPTR Implantstwo years

Countries

Switzerland

Contacts

Primary ContactChristian Plaass, MD
Christian@Plaass.info+49 152 29098211
Backup ContactCarol Claudius Hasler, MD, PhD
Carolclaudius.hasler@ukbb.ch+41 685 5350

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026