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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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E04.525.190, Craniotomy, Craniectomy

Intervention / Treatment
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* Device: PSI in PEEK


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PSI in PEEK<br>All study subjects have received a Patient Specific Implant (PSI) made of PEEK to repair a cranial defect | Device: PSI in PEEK<br>* A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect<br>* Other names: Patient Specific Implant in Polyether Ether Ketone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explantation | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cranial defect, PSI, patient specific implant, PEEK, polyether ether ketone, craniectomy, craniotomy