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

Sponsor

Synthes GmbH (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01282645

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
E04.525.190 Craniotomy Craniectomy	Device: PSI in PEEK

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jul 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2012

Anticipated Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
PSI in PEEK All study subjects have received a Patient Specific Implant (PSI) made of PEEK to repair a cranial defect	Device: PSI in PEEK A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect Other Names: Patient Specific Implant in Polyether Ether Ketone

Arm

Intervention/Treatment

PSI in PEEK

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

Device: PSI in PEEK

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

Other Names:

Patient Specific Implant in Polyether Ether Ketone

Outcome Measures

Primary Outcome Measures

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

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 [surgery - at discharge]
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)
Cosmetic 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)
Clinical result [surgery - at discharge]
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)
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)
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)
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	AKH Allgemeines Krankenhaus	Wien	Austria
2	Hôpital Erasme ULB	Brussels	Belgium
3	Hospital San Pablo de Coquimbo	Coquimbo	Chile
4	Hospital de Trabajador de Santiago	Santiago de Chile	Chile
5	Hospital San José	Bogotá	Colombia
6	Hospital Universitario San Ignacio	Bogotá	Colombia
7	Instituto Roosevelt	Bogotá	Colombia
8	Hospital Universitario del Valle	Santiago de Cali	Colombia
9	Hospital Clinica Biblica	Cartago	Costa Rica
10	University Hospital	Ostrava	Czech Republic
11	Rigshospital	Copenhagen	Denmark
12	Oulu University Hospital	Oulu	Finland
13	Centre Hospitalier Universitaire	Toulouse	France
14	Universitätsklinikum Aachen	Aachen	Germany
15	HELIOS-Klinikum Emil von Behring	Berlin	Germany
16	Universitätsklinikum Düsseldorf	Düsseldorf	Germany
17	Clemenshospital Münster	Heidelberg	Germany
18	Universitätsklinikum Heidelberg	Heidelberg	Germany
19	Hospital da Universidade	Coimbra	Portugal
20	National Neuroscience Institute	Singapore	Singapore
21	Hospital 12 de Octubre	Madrid	Spain
22	Ramon y Cajal Hospital	Madrid	Spain
23	Clinica Universitaria Navarra	Pamplona	Spain
24	Inselspital	Bern	Switzerland
25	Hôpital Cantonal Universitaire	Genève	Switzerland
26	Centre Hospitalier Universitaire Vaudois	Lausanne	Switzerland
27	Kantonsspital St- Gallen	St. Gallen	Switzerland
28	Universitätsspital Zürich	Zürich	Switzerland
29	Queen Victoria Hospital	East Grinstead	United Kingdom
30	The Walton Center	Liverpool	United Kingdom