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

Synthes GmbH30 sites in 15 countriesJuly 2011

ConditionsE04.525.190 Craniotomy Craniectomy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: E04.525.190
Sponsor: Synthes GmbH
Locations: 30
Primary Endpoint: Device related adverse events
Status: Withdrawn
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

January 2012

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Synthes GmbH

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Device related adverse events

Time Frame: 0-24 months post initial implantation

Percentage of patients with the following device related adverse events: * infection * rejection * dislocation * fracture

Secondary Outcomes

Explantation(0 months - study visit at least 24 months after implantation (or scheduled up to 3 months after the study visit))
Cosmetic result(At the study visit, which is at least 24 months after implantation)
Clinical result(At the study visit, which is at least 24 months after implantation)
Pressure sensitivity(At the study visit, which is at least 24 months after implantation)
Heat / cold sensitivity(At the study visit, which is at least 24 months after implantation)
Event-free survival(0 months - at the study visit, which is at least 24 months after implantation)