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

Synthes GmbH

Overview

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.

Study Type

OBSERVATIONAL

Conditions

E04.525.190 Craniotomy Craniectomy

Interventions

PSI in PEEKDEVICE

A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (30)

AKH Allgemeines Krankenhaus

Vienna, Austria

Outcomes

Primary Outcomes

Device related adverse events

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

Time frame: 0-24 months post initial implantation

Secondary Outcomes

Explantation

Explantation, as a result of a device-related adverse event or for another reason

Time frame: 0 months - study visit at least 24 months after implantation (or scheduled up to 3 months after the study visit)

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)

Time frame: surgery - at discharge

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)

Time frame: at the study visit, which is at least 24 months after implantation

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)

Time frame: surgery - at discharge

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)

Time frame: At the study visit, which is at least 24 months after implantation

Pressure sensitivity

Data from ClinicalTrials.gov

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