InfectionNCT01085669
Infection Rate of Vertical Expandable Prosthetic Titanium Rib Implants (VEPTR)
An observational study of Infection, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The study is conducted to analyse the infection rate in children treated with VEPTR-Implants for severe spine or thoracic deformities. Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Infection
- What is being tested?
- Microbiological analysis of retained VEPTR Implants
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2009to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- all patients admitted at the University Children's Hospital Basel in whom a VEPTR©-implant or parts of it will be removed.
Who cannot join
- obvious contamination of an explanted component occurred in the operating room.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Orthopaedic Department, University Children´s Hospital Basel
Basel, 4005
Daniel Studer, MD, +41 685 6565, Daniel.Studer@ukbb.ch
Carol Claudius Hasler, MD, PhD, +41 685 5350, Carolclaudius.hasler@ukbb.ch
About this study
Official title: Infection Rate of VEPTR-Implants in Children With Severe Spinal and Thoracic Deformities
The study is conducted to analyse the infection rate in children treated with VEPTR-Implants for severe spine or thoracic deformities.
Read the 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.
- Conditions
- Infection
- Being tested
- Microbiological analysis of retained VEPTR Implants
- Keywords
- Infection rate of VEPTR-Implants, VEPTR. Vertical Expandable, Prosthetic Titanium Rib
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological analysis of retained VEPTR ImplantsDevice
Implants have to be adapted every half a year, the retained implants during revision are analysed for biological colonization.
| Study group | Role | What they receive |
|---|---|---|
| VEPTR patients | Children treated with VEPTR Implants for severe spinal or thoracic deformities Receives: Device: Microbiological analysis of retained VEPTR Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rate of VEPTR Implants
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2011 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085669
- Sponsor's protocol ID
- EKBB 304/09
- Status last verified
- Mar 2010
- First submitted
- 11 Mar 2010
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infection Rate of VEPTR-Implants in Children With Severe Spinal and Thoracic Deformities
- ClinicalTrials.gov ID
- NCT01085669
- Acronym / sponsor ID
- EKBB 304/09
- Conditions
- Infection
- Keywords
- Infection rate of VEPTR-Implants, VEPTR. Vertical Expandable, Prosthetic Titanium Rib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is conducted to analyse the infection rate in children treated with VEPTR-Implants for severe spine or thoracic deformities.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VEPTR patients | – | Device: Microbiological analysis of retained VEPTR ImplantsChildren treated with VEPTR Implants for severe spinal or thoracic deformities |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- all patients admitted at the University Children's Hospital Basel in whom a VEPTR©-implant or parts of it will be removed.
Key exclusion criteria (1 listed)
- obvious contamination of an explanted component occurred in the operating room.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiological analysis of retained VEPTR ImplantsImplants have to be adapted every half a year, the retained implants during revision are analysed for biological colonization. | Device | VEPTR patients |
Primary outcome
Infection rate of VEPTR Implants
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Plaass, MD (+49 152 29098211, Christian@Plaass.info), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection rate of VEPTR Implants (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2010.