Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years
NCT ID: NCT01282645
Last Updated: 2013-03-22
Study Results
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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WITHDRAWN
OBSERVATIONAL
2011-07-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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PSI in PEEK
All study subjects have received a Patient Specific Implant (PSI) made of PEEK to repair a cranial defect
PSI in PEEK
A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect
Interventions
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PSI in PEEK
A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received a Synthes PSI® made of PEEK intended for replacement of bony voids in the cranial/craniofacial skeleton at least 24 months before inclusion in the study
* Ability to obtain written informed consent from the recipient or the recipient's legal guardian
* Ability to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Synthes GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Frédéric Lauwers, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Toulouse, Toulouse, France
Locations
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AKH Allgemeines Krankenhaus
Vienna, , Austria
Hôpital Erasme ULB
Brussels, , Belgium
Hospital San Pablo de Coquimbo
Coquimbo, , Chile
Hospital de Trabajador de Santiago
Santiago, , Chile
Hospital San José
Bogotá, , Colombia
Hospital Universitario San Ignacio
Bogotá, , Colombia
Instituto Roosevelt
Bogotá, , Colombia
Hospital Universitario del Valle
Santiago de Cali, , Colombia
Hospital Clinica Biblica
Cartago, , Costa Rica
University Hospital
Ostrava, , Czechia
Rigshospital
Copenhagen, , Denmark
Oulu University Hospital
Oulu, , Finland
Centre Hospitalier Universitaire
Toulouse, , France
Universitätsklinikum Aachen
Aachen, , Germany
HELIOS-Klinikum Emil von Behring
Berlin, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Clemenshospital Münster
Heidelberg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Hospital da Universidade
Coimbra, , Portugal
National Neuroscience Institute
Singapore, , Singapore
Hospital 12 de Octubre
Madrid, , Spain
Ramon y Cajal Hospital
Madrid, , Spain
Clinica Universitaria Navarra
Pamplona, , Spain
Inselspital
Bern, , Switzerland
Hôpital Cantonal Universitaire
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Kantonsspital St- Gallen
Sankt Gallen, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Queen Victoria Hospital
East Grinstead, , United Kingdom
The Walton Center
Liverpool, , United Kingdom
Countries
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Other Identifiers
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STU-CMF-C-16-204-01
Identifier Type: -
Identifier Source: org_study_id
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