Infection Rate of Vertical Expandable Prosthetic Titanium Rib Implants (VEPTR)
Infection Rate of VEPTR-Implants in Children With Severe Spinal and Thoracic Deformities
1 other identifier
observational
50
1 country
1
Brief Summary
The study is conducted to analyse the infection rate in children treated with VEPTR-Implants for severe spine or thoracic deformities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 11, 2010
CompletedFirst Posted
Study publicly available on registry
March 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMarch 12, 2010
March 1, 2010
2.2 years
March 11, 2010
March 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infection rate of VEPTR Implants
two years
Study Arms (1)
VEPTR patients
Children treated with VEPTR Implants for severe spinal or thoracic deformities
Interventions
Implants have to be adapted every half a year, the retained implants during revision are analysed for biological colonization.
Eligibility Criteria
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.
You may qualify if:
- all patients admitted at the University Children's Hospital Basel in whom a VEPTR©-implant or parts of it will be removed.
You may not qualify if:
- obvious contamination of an explanted component occurred in the operating room.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orthopaedic Department, University Children´s Hospital Basel
Basel, 4005, Switzerland
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 11, 2010
First Posted
March 12, 2010
Study Start
September 1, 2009
Primary Completion
December 1, 2011
Study Completion
May 1, 2012
Last Updated
March 12, 2010
Record last verified: 2010-03