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

March 21, 2013 updated by: Synthes GmbH

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • AKH Allgemeines Krankenhaus
  • Belgium
      • Brussels, Belgium
        • Hôpital Erasme ULB
  • Chile
      • Coquimbo, Chile
        • Hospital San Pablo de Coquimbo
      • Santiago de Chile, Chile
        • Hospital de Trabajador de Santiago
  • Colombia
      • Bogotá, Colombia
        • Hospital Universitario San Ignacio
      • Bogotá, Colombia
        • Hospital San José
      • Bogotá, Colombia
        • Instituto Roosevelt
      • Santiago de Cali, Colombia
        • Hospital Universitario del Valle
  • Costa Rica
      • Cartago, Costa Rica
        • Hospital Clínica Bíblica
  • Czech Republic
      • Ostrava, Czech Republic
        • University Hospital
  • Denmark
      • Copenhagen, Denmark
        • Rigshospital
  • Finland
      • Oulu, Finland
        • Oulu University Hospital
  • France
      • Toulouse, France
        • Centre Hospitalier Universitaire
  • Germany
      • Aachen, Germany
        • Universitätsklinikum Aachen
      • Berlin, Germany
        • HELIOS-Klinikum Emil von Behring
      • Düsseldorf, Germany
        • Universitätsklinikum Düsseldorf
      • Heidelberg, Germany
        • Universitätsklinikum Heidelberg
      • Heidelberg, Germany
        • Clemenshospital Münster
  • Portugal
      • Coimbra, Portugal
        • Hospital da Universidade
  • Singapore
      • Singapore, Singapore
        • National Neuroscience Institute
  • Spain
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Ramón y Cajal Hospital
      • Pamplona, Spain
        • Clínica Universitaria Navarra
  • Switzerland
      • Bern, Switzerland
        • Inselspital
      • Genève, Switzerland
        • Hôpital Cantonal Universitaire
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
      • St. Gallen, Switzerland
        • Kantonsspital St- Gallen
      • Zürich, Switzerland
        • UniversitätsSpital Zürich
  • United Kingdom
      • East Grinstead, United Kingdom
        • Queen Victoria Hospital
      • Liverpool, United Kingdom
        • The Walton Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In 30 clinics worldwide, all patients who received a PSI in PEEK at least 2 years ago, who fullfil the in-and exclusion criteria, will be asked to participate

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-24 months post initial implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explantation
Time Frame: 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
0 months - study visit at least 24 months after implantation (or scheduled up to 3 months after the study visit)
Cosmetic result
Time Frame: 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)
surgery - at discharge
Cosmetic result
Time Frame: 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)
at the study visit, which is at least 24 months after implantation
Clinical result
Time Frame: 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)
surgery - at discharge
Clinical result
Time Frame: 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)
At the study visit, which is at least 24 months after implantation
Pressure sensitivity
Time Frame: 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)
At the study visit, which is at least 24 months after implantation
Heat / cold sensitivity
Time Frame: 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)
At the study visit, which is at least 24 months after implantation
Cosmetic result
Time Frame: 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)
At the study visit, which is at least 24 months after implantation
Event-free survival
Time Frame: 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]
0 months - at the study visit, which is at least 24 months after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synthes GmbH

Investigators

  • Principal Investigator: Frédéric Lauwers, MD, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

January 24, 2011

First Posted (Estimate)

January 25, 2011

Study Record Updates

Last Update Posted (Estimate)

March 22, 2013

Last Update Submitted That Met QC Criteria

March 21, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU-CMF-C-16-204-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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