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

March 11, 2010 updated by: Centre Hospitalier Universitaire Vaudois

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4005
        • Recruiting
        • Orthopaedic Department, University Children´s Hospital Basel
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Studer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with severe spinal or throacic deformities treates with VEPTR-implants. In these patients the implant has to be revised every half a year due to grow and achieved correction.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VEPTR patients
Children treated with VEPTR Implants for severe spinal or thoracic deformities
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infection rate of VEPTR Implants
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Collaborators

University Children's Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (Estimate)

March 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 12, 2010

Last Update Submitted That Met QC Criteria

March 11, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKBB 304/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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