NCT01282645

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.

Trial Health

42
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
14 countries

26 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

6 months

First QC Date

January 24, 2011

Last Update Submit

March 21, 2013

Conditions

E04.525.190CraniotomyCraniectomy

Keywords

Cranial defectPSIpatient specific implantPEEKpolyether ether ketonecraniectomycraniotomy

Outcome Measures

Primary Outcomes (1)

  • Device related adverse events

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

    0-24 months post initial implantation

Secondary Outcomes (9)

  • Explantation

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

  • Cosmetic result

    surgery - at discharge

  • Cosmetic result

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

  • Clinical result

    surgery - at discharge

  • Clinical result

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

  • +4 more secondary outcomes

Study Arms (1)

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

Interventions

PSI in PEEKDEVICE

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

Also known as: Patient Specific Implant in Polyether Ether Ketone
PSI in PEEK

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patient was contraindicated to receive a PSI made of PEEK at the time of implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

AKH Allgemeines Krankenhaus

Vienna, Austria

Location

Hôpital Erasme ULB

Brussels, Belgium

Location

Hospital San Pablo de Coquimbo

Coquimbo, Chile

Location

Hospital de Trabajador de Santiago

Santiago, Chile

Location

Hospital San José

Bogotá, Colombia

Location

Hospital Universitario San Ignacio

Bogotá, Colombia

Location

Instituto Roosevelt

Bogotá, Colombia

Location

Hospital Universitario del Valle

Santiago de Cali, Colombia

Location

Hospital Clinica Biblica

Cartago, Costa Rica

Location

University Hospital

Ostrava, Czechia

Location

Rigshospital

Copenhagen, Denmark

Location

Oulu University Hospital

Oulu, Finland

Location

Centre Hospitalier Universitaire

Toulouse, France

Location

Universitätsklinikum Aachen

Aachen, Germany

Location

HELIOS-Klinikum Emil von Behring

Berlin, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Clemenshospital Münster

Heidelberg, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Hospital da Universidade

Coimbra, Portugal

Location

National Neuroscience Institute

Singapore, Singapore

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Ramon y Cajal Hospital

Madrid, Spain

Location

Clinica Universitaria Navarra

Pamplona, Spain

Location

Inselspital

Bern, Switzerland

Location

Hôpital Cantonal Universitaire

Geneva, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Kantonsspital St- Gallen

Sankt Gallen, Switzerland

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

Queen Victoria Hospital

East Grinstead, United Kingdom

Location

The Walton Center

Liverpool, United Kingdom

Location

Study Officials

  • Frédéric Lauwers, MD

    Centre Hospitalier Universitaire de Toulouse, Toulouse, France

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2011

First Posted

January 25, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

PT(1)SG(1)FR(1)CO(1)DE(5)ES(3)CH(5)CL(2)AU(1)FI(1)CZ(1)DK(1)GB(2)BE(1)