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

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ClinicalTrials.gov Identifier: NCT01282645
Recruitment Status : Withdrawn
First Posted : January 25, 2011
Last Update Posted : March 22, 2013
Sponsor:
Information provided by (Responsible Party):
Synthes GmbH

January 24, 2011
January 25, 2011
March 22, 2013
July 2011
January 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01282645 on ClinicalTrials.gov Archive Site
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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]
Same as current
Not Provided
Not Provided
 
Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
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
  • E04.525.190
  • Craniotomy
  • Craniectomy
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
PSI in PEEK
All study subjects have received a Patient Specific Implant (PSI) made of PEEK to repair a cranial defect
Intervention: Device: PSI in PEEK
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
80
January 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Chile,   Colombia,   Costa Rica,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Portugal,   Singapore,   Spain,   Switzerland,   United Kingdom
 
 
NCT01282645
STU-CMF-C-16-204-01
No
Not Provided
Not Provided
Synthes GmbH
Synthes GmbH
Not Provided
Principal Investigator: Frédéric Lauwers, MD Centre Hospitalier Universitaire de Toulouse, Toulouse, France
Synthes GmbH
March 2013