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

Withdrawn

• Conditions: E04.525.190; Craniotomy; Craniectomy

• 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• Status: WITHDRAWN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

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

Hôpital Erasme ULB; 🇧🇪 Brussels, Belgium

Hospital San Pablo de Coquimbo; 🇨🇱 Coquimbo, Chile

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

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