Clinical trial NCT01282645: Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years
Official title: A Retrospective Case Series to Evaluate the Long Term Outcome of the Use of Synthes Patient Specific Implants (PSI®) Made of Polyether Ether Ketone (PEEK) for the Treatment of Cranial Defects in Patients With a Mature Skeleton
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: E04.525.190
Craniotomy
Craniectomy
Keywords: Cranial defect
PSI
patient specific implant
PEEK
polyether ether ketone
craniectomy
craniotomy
Lead sponsor: Synthes GmbH
Sponsor class: INDUSTRY
First posted: 2011-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In 30 clinics worldwide, all patients who received a PSI in PEEK at least 2 years ago, who fullfil the in-and exclusion criteria, will be asked to participate

Brief summary: The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.


Eligibility criteria: Inclusion Criteria:

* Males or females age 18 years or over at the time of inclusion into the study
* 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:

* Patient was contraindicated to receive a PSI made of PEEK at the time of implantation

Primary outcomes:
measure: Device related adverse events
timeFrame: 0-24 months post initial implantation
Secondary outcomes:
measure: Explantation
timeFrame: 0 months - study visit at least 24 months after implantation (or scheduled up to 3 months after the study visit)
measure: Cosmetic result
timeFrame: surgery - at discharge
measure: Cosmetic result
timeFrame: at the study visit, which is at least 24 months after implantation
measure: Clinical result
timeFrame: surgery - at discharge
measure: Clinical result
timeFrame: At the study visit, which is at least 24 months after implantation
measure: Pressure sensitivity
timeFrame: At the study visit, which is at least 24 months after implantation
measure: Heat / cold sensitivity
timeFrame: At the study visit, which is at least 24 months after implantation
measure: Cosmetic result
timeFrame: At the study visit, which is at least 24 months after implantation
measure: Event-free survival
timeFrame: 0 months - at the study visit, which is at least 24 months after implantation
Other outcomes:
Locations:
city: Wien
country: Austria
facility: AKH Allgemeines Krankenhaus
city: Brussels
country: Belgium
facility: Hôpital Erasme ULB
city: Coquimbo
country: Chile
facility: Hospital San Pablo de Coquimbo
city: Santiago de Chile
country: Chile
facility: Hospital de Trabajador de Santiago
city: Bogotá
country: Colombia
facility: Hospital San José
city: Bogotá
country: Colombia
facility: Hospital Universitario San Ignacio
city: Bogotá
country: Colombia
facility: Instituto Roosevelt
city: Santiago de Cali
country: Colombia
facility: Hospital Universitario del Valle
city: Cartago
country: Costa Rica
facility: Hospital Clinica Biblica
city: Ostrava
country: Czech Republic
facility: University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Berlin
country: Germany
facility: HELIOS-Klinikum Emil von Behring
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Heidelberg
country: Germany
facility: Clemenshospital Münster
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Coimbra
country: Portugal
facility: Hospital da Universidade
city: Singapore
country: Singapore
facility: National Neuroscience Institute
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Ramon y Cajal Hospital
city: Pamplona
country: Spain
facility: Clinica Universitaria Navarra
city: Bern
country: Switzerland
facility: Inselspital
city: Genève
country: Switzerland
facility: Hôpital Cantonal Universitaire
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: St. Gallen
country: Switzerland
facility: Kantonsspital St- Gallen
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital
city: Liverpool
country: United Kingdom
facility: The Walton Center
Study officials:
affiliation: Centre Hospitalier Universitaire de Toulouse, Toulouse, France
name: Frédéric Lauwers, MD
role: PRINCIPAL_INVESTIGATOR
References: