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

NCT ID: NCT01085669

Last Updated: 2010-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-05-31

Brief Summary

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The study is conducted to analyse the infection rate in children treated with VEPTR-Implants for severe spine or thoracic deformities.

Detailed Description

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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.

Conditions

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Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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VEPTR patients

Children treated with VEPTR Implants for severe spinal or thoracic deformities

Microbiological analysis of retained VEPTR Implants

Intervention Type DEVICE

Implants have to be adapted every half a year, the retained implants during revision are analysed for biological colonization.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Children's Hospital Basel

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Orthopaedic Department, University Children´s Hospital Basel

Locations

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Orthopaedic Department, University Children´s Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Christian Plaass, MD

Role: CONTACT

+49 152 29098211

Carol Claudius Hasler, MD, PhD

Role: CONTACT

+41 685 5350

Facility Contacts

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Daniel Studer, MD

Role: primary

+41 685 6565

Carol Claudius Hasler, MD, PhD

Role: backup

+41 685 5350

Other Identifiers

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EKBB 304/09

Identifier Type: -

Identifier Source: org_study_id

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