Infection Rate of Vertical Expandable Prosthetic Titanium Rib Implants (VEPTR)
Recruitment status was Recruiting
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Purpose
The study is conducted to analyse the infection rate in children treated with VEPTR-Implants for severe spine or thoracic deformities.
| Condition | Intervention |
|---|---|
|
Infection |
Device: Microbiological analysis of retained VEPTR Implants |
| Study Type: | Observational |
| 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 ]
| Estimated Enrollment: | 50 |
| 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) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 1 Year to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and Locations| Contact: Christian Plaass, MD | +49 152 29098211 | Christian@Plaass.info |
| Contact: Carol Claudius Hasler, MD, PhD | +41 685 5350 | Carolclaudius.hasler@ukbb.ch |
| Switzerland | |
| 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.hasler@ukbb.ch | |
| Principal Investigator: Daniel Studer, MD | |
More Information
No publications provided
| Responsible Party: | PD Dr. Carol-C. Hasler, Head Spine Surgery, Orthopaedic Department, University Children´s Hospital Basel |
| ClinicalTrials.gov Identifier: | NCT01085669 History of Changes |
| Other Study ID Numbers: | EKBB 304/09 |
| Study First Received: | March 11, 2010 |
| Last Updated: | March 11, 2010 |
| Health Authority: | Switzerland: Institutional Review Board |
Keywords provided by Centre Hospitalier Universitaire Vaudois:
|
Infection rate of VEPTR-Implants VEPTR. Vertical Expandable Prosthetic Titanium Rib |
ClinicalTrials.gov processed this record on June 17, 2013