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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Synthes GmbH
ClinicalTrials.gov Identifier:
NCT01282645
First received: January 24, 2011
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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 Intervention
E04.525.190
Craniotomy
Craniectomy
Device: PSI in PEEK

Study Type: Observational
Study Design: 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

Further study details as provided by Synthes GmbH:

Primary Outcome Measures:
  • Device related adverse events [ Time Frame: 0-24 months post initial implantation ] [ Designated as safety issue: Yes ]

    Percentage of patients with the following device related adverse events:

    • infection
    • rejection
    • dislocation
    • fracture


Secondary Outcome Measures:
  • Explantation [ Time Frame: 0 months - study visit at least 24 months after implantation (or scheduled up to 3 months after the study visit) ] [ Designated as safety issue: No ]
    Explantation, as a result of a device-related adverse event or for another reason

  • Cosmetic result [ Time Frame: surgery - at discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: at the study visit, which is at least 24 months after implantation ] [ Designated as safety issue: No ]
    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 [ Time Frame: surgery - at discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the study visit, which is at least 24 months after implantation ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the study visit, which is at least 24 months after implantation ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the study visit, which is at least 24 months after implantation ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the study visit, which is at least 24 months after implantation ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0 months - at the study visit, which is at least 24 months after implantation ] [ Designated as safety issue: Yes ]

    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]


Enrollment: 0
Study Start Date: July 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Patient Specific Implant in Polyether Ether Ketone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282645

  Show 30 Study Locations
Sponsors and Collaborators
Synthes GmbH
Investigators
Principal Investigator: Frédéric Lauwers, MD Centre Hospitalier Universitaire de Toulouse, Toulouse, France
  More Information

No publications provided

Responsible Party: Synthes GmbH
ClinicalTrials.gov Identifier: NCT01282645     History of Changes
Other Study ID Numbers: STU-CMF-C-16-204-01
Study First Received: January 24, 2011
Last Updated: March 21, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Conseil National de l'Ordre des Médecins
France: Institutional Ethical Committee

Keywords provided by Synthes GmbH:
Cranial defect
PSI
patient specific implant
PEEK
polyether ether ketone
craniectomy
craniotomy

ClinicalTrials.gov processed this record on April 23, 2014