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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Centre Hospitalier Universitaire Vaudois.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Children's Hospital Basel
Information provided by:
Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01085669
First received: March 11, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  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

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • 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
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085669

Contacts
Contact: Christian Plaass, MD +49 152 29098211 Christian@Plaass.info
Contact: Carol Claudius Hasler, MD, PhD +41 685 5350 Carolclaudius.hasler@ukbb.ch

Locations
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
University Children's Hospital Basel
  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 July 26, 2014