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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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 Jose
      • Bogotá, Colombia
        • Instituto Roosevelt
      • Santiago de Cali, Colombia
        • Hospital Universitario del Valle
  • Costa Rica
      • Cartago, Costa Rica
        • Hospital Clínica Biblica
  • 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
        • Universitatsklinikum 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Synthes GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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