Craniectomy, Craniotomy, E04.525.190
Conditions
Keywords
Cranial defect, PSI, patient specific implant, PEEK, polyether ether ketone, craniectomy, craniotomy
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.
Interventions
DEVICEPSI in PEEK
A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect
Sponsors
Synthes GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device related adverse events | 0-24 months post initial implantation | Percentage of patients with the following device related adverse events: * infection * rejection * dislocation * fracture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic result | 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) |
| Clinical result | 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) |
| Explantation | 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 |
| Heat / cold sensitivity | 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) |
| Event-free survival | 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 \[Time frame 0 months - study visit\] |
| Pressure sensitivity | 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) |
Countries
Austria, Belgium, Chile, Colombia, Costa Rica, Czechia, Denmark, Finland, France, Germany, Portugal, Singapore, Spain, Switzerland, United Kingdom
Outcome results
None listed