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

DePuy Synthes

Status: Withdrawn

Conditions: Craniectomy; Craniotomy; E04.525.190

Treatments: Device: PSI in PEEK

Study type: Observational

Funder types: Industry

Identifiers

NCT01282645

STU-CMF-C-16-204-01

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

PSI in PEEK

Description:

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

Treatment:

Device: PSI in PEEK