- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01085669
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 Contact
- Name: Christian Plaass, MD
- Phone Number: +49 152 29098211
- Email: Christian@Plaass.info
Study Contact Backup
- Name: Carol Claudius Hasler, MD, PhD
- Phone Number: +41 685 5350
- Email: Carolclaudius.hasler@ukbb.ch
Study Locations
-
-
-
Basel, Switzerland, 4005
- Recruiting
- Orthopaedic Department, University Children´s Hospital Basel
-
Contact:
- Carol Claudius Hasler, MD, PhD
- Phone Number: +41 685 5350
- Email: Carolclaudius.hasler@ukbb.ch
-
Contact:
- Daniel Studer, MD
- Phone Number: +41 685 6565
- Email: Daniel.Studer@ukbb.ch
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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
|
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.
Collaborators
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
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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Clinical Trials on Microbiological analysis of retained VEPTR Implants
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-
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Istituto Ortopedico RizzoliCompleted
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ElsanNot yet recruiting