NCT01085669

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 12, 2010

Status Verified

March 1, 2010

Enrollment Period

2.2 years

First QC Date

March 11, 2010

Last Update Submit

March 11, 2010

Conditions

Keywords

Infection rate of VEPTR-ImplantsVEPTR. Vertical ExpandableProsthetic Titanium Rib

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

Device: Microbiological analysis of retained VEPTR Implants

Interventions

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

VEPTR patients

Eligibility Criteria

Age1 Year - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

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

RECRUITING

MeSH Terms

Conditions

Infections

Central Study Contacts

Christian Plaass, MD

CONTACT

Carol Claudius Hasler, MD, PhD

CONTACT

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

Locations