Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years

Craniotomy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01282645
• Other study ID #: STU-CMF-C-16-204-01
• Status: Withdrawn
• Phase: N/A
• First received: January 24, 2011
• Last updated: March 21, 2013
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: March 2013
• Source: Synthes GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Conseil National de l'Ordre des MédecinsFrance: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Craniectomy
• Craniotomy
• E04.525.190

Intervention

Device:
• PSI in PEEK
A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect

Locations

Country	Name	City	State
Austria	AKH Allgemeines Krankenhaus	Wien
Belgium	Hôpital Erasme ULB	Brussels
Chile	Hospital San Pablo de Coquimbo	Coquimbo
Chile	Hospital de Trabajador de Santiago	Santiago de Chile
Colombia	Hospital San José	Bogotá
Colombia	Hospital Universitario San Ignacio	Bogotá
Colombia	Instituto Roosevelt	Bogotá
Colombia	Hospital Universitario del Valle	Santiago de Cali
Costa Rica	Hospital Clinica Biblica	Cartago
Czech Republic	University Hospital	Ostrava
Denmark	Rigshospital	Copenhagen
Finland	Oulu University Hospital	Oulu
France	Centre Hospitalier Universitaire	Toulouse
Germany	Universitätsklinikum Aachen	Aachen
Germany	HELIOS-Klinikum Emil von Behring	Berlin
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Clemenshospital Münster	Heidelberg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Portugal	Hospital da Universidade	Coimbra
Singapore	National Neuroscience Institute	Singapore
Spain	Hospital 12 de Octubre	Madrid
Spain	Ramon y Cajal Hospital	Madrid
Spain	Clinica Universitaria Navarra	Pamplona
Switzerland	Inselspital	Bern
Switzerland	Hôpital Cantonal Universitaire	Genève
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Kantonsspital St- Gallen	St. Gallen
Switzerland	Universitätsspital Zürich	Zürich
United Kingdom	Queen Victoria Hospital	East Grinstead
United Kingdom	The Walton Center	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Synthes GmbH

Countries where clinical trial is conducted

Austria,  Belgium,  Chile,  Colombia,  Costa Rica,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Portugal,  Singapore,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device related adverse events	Percentage of patients with the following device related adverse events: infection; rejection; dislocation; fracture	0-24 months post initial implantation	Yes
Secondary	Explantation	Explantation, as a result of a device-related adverse event or for another reason	0 months - study visit at least 24 months after implantation (or scheduled up to 3 months after the study visit)	No
Secondary	Cosmetic result	Evaluation of the cosmetic result by the surgeon by means of a VAS 0-100, immediately after the surgery or until the patient was discharged from the hospital (any timepoint available)	surgery - at discharge	No
Secondary	Cosmetic result	Evaluation of the cosmetic result by the surgeon by means of a VAS 0-100, during the study visit, at least 24 months after implantation (see inclusion criteria)	at the study visit, which is at least 24 months after implantation	No
Secondary	Clinical result	Evaluation of the clinical result by the surgeon by means of a VAS 0-100, immediately after the surgery or until the patient was discharged from the hospital (any timepoint available)	surgery - at discharge	No
Secondary	Clinical result	Evaluation of the cosmetic result by the surgeon by means of a VAS 0-100, during the study visit, at least 24 months after implantation (see inclusion criteria)	At the study visit, which is at least 24 months after implantation	No
Secondary	Pressure sensitivity	Evaluation of the pressure sensitivity by the patient (or next of kin appreciation in case of severe disability) by means of a VAS 0-100, during the study visit, at least 24 months after implantation (see inclusion criteria)	At the study visit, which is at least 24 months after implantation	No
Secondary	Heat / cold sensitivity	Evaluation of the heat/cold sensitivity by the patient (or next of kin appreciation in case of severe disability) by means of a VAS 0-100, during the study visit, at least 24 months after implantation (see inclusion criteria)	At the study visit, which is at least 24 months after implantation	No
Secondary	Cosmetic result	Evaluation of the cosmetic result by the patient (or next of kin in case of severe disability) by means of a VAS 0-100, during the study visit, at least 24 months after implantation (see inclusion criteria)	At the study visit, which is at least 24 months after implantation	No
Secondary	Event-free survival	Number of months of event-free survival, in terms of device related adverse events: Infection (superficial and/or deep) [Time frame 0 months - study visit]; Rejection of the implant [Time frame 0 months - study visit]; Dislocation of the implant [Time frame 0 months - study visit]; Fracture of the implant [Time frame 0 months - study visit]	0 months - at the study visit, which is at least 24 months after implantation	Yes