Infection Rate of Vertical Expandable Prosthetic Titanium Rib Implants (VEPTR)
Recruitment status was Recruiting
The study is conducted to analyse the infection rate in children treated with VEPTR-Implants for severe spine or thoracic deformities.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Infection Rate of VEPTR-Implants in Children With Severe Spinal and Thoracic Deformities|
- Infection rate of VEPTR Implants [ Time Frame: two years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085669
|Contact: Christian Plaass, MD||+49 152 29098211||Christian@Plaass.info|
|Contact: Carol Claudius Hasler, MD, PhD||+41 685 5350||Carolclaudius.email@example.com|
|Orthopaedic Department, University Children´s Hospital Basel||Recruiting|
|Basel, Switzerland, 4005|
|Contact: Daniel Studer, MD +41 685 6565 Daniel.Studer@ukbb.ch|
|Contact: Carol Claudius Hasler, MD, PhD +41 685 5350 Carolclaudius.firstname.lastname@example.org|
|Principal Investigator: Daniel Studer, MD|