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

Withdrawn

• Conditions: E04.525.190; Craniotomy; Craniectomy
• Interventions: Device: PSI in PEEK

• Registration Number: NCT01282645
• Lead Sponsor: Synthes GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Study Start: 2011-07
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PSI in PEEK	PSI in PEEK	All study subjects have received a Patient Specific Implant (PSI) made of PEEK to repair a cranial defect

Primary Outcome Measures

Name	Time	Method
Device related adverse events	0-24 months post initial implantation	Percentage of patients with the following device related adverse events: * infection; * rejection; * dislocation; * fracture

Secondary Outcome Measures

Name	Time	Method
Explantation	0 months - study visit at least 24 months after implantation (or scheduled up to 3 months after the study visit)	Explantation, as a result of a device-related adverse event or for another reason
Cosmetic result	At the study visit, which is at least 24 months after implantation	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)
Clinical result	At the study visit, which is at least 24 months after implantation	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)
Pressure sensitivity	At the study visit, which is at least 24 months after implantation	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)
Heat / cold sensitivity	At the study visit, which is at least 24 months after implantation	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)
Event-free survival	0 months - at the study visit, which is at least 24 months after implantation	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 \[Time frame 0 months - study visit\]

Trial Locations

Locations (30)

AKH Allgemeines Krankenhaus; 🇦🇹 Wien, Austria

Hospital San Pablo de Coquimbo; 🇨🇱 Coquimbo, Chile

Hôpital Erasme ULB; 🇧🇪 Brussels, Belgium

Rigshospital; 🇩🇰 Copenhagen, Denmark

Hospital Clinica Biblica; 🇨🇷 Cartago, Costa Rica

Centre Hospitalier Universitaire; 🇫🇷 Toulouse, France

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

HELIOS-Klinikum Emil von Behring; 🇩🇪 Berlin, Germany

Clemenshospital Münster; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Hospital da Universidade; 🇵🇹 Coimbra, Portugal

Hôpital Cantonal Universitaire; 🇨🇭 Genève, Switzerland

National Neuroscience Institute; 🇸🇬 Singapore, Singapore

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Clinica Universitaria Navarra; 🇪🇸 Pamplona, Spain

Inselspital; 🇨🇭 Bern, Switzerland

Queen Victoria Hospital; 🇬🇧 East Grinstead, United Kingdom

The Walton Center; 🇬🇧 Liverpool, United Kingdom

Ramon y Cajal Hospital; 🇪🇸 Madrid, Spain

Hospital San José; 🇨🇴 Bogotá, Colombia

Oulu University Hospital; 🇫🇮 Oulu, Finland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kantonsspital St- Gallen; 🇨🇭 St. Gallen, Switzerland

Hospital de Trabajador de Santiago; 🇨🇱 Santiago de Chile, Chile

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland

Hospital Universitario San Ignacio; 🇨🇴 Bogotá, Colombia

Instituto Roosevelt; 🇨🇴 Bogotá, Colombia

Hospital Universitario del Valle; 🇨🇴 Santiago de Cali, Colombia

University Hospital; 🇨🇿 Ostrava, Czech Republic