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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSI in PEEK | All study subjects have received a Patient Specific Implant (PSI) made of PEEK to repair a cranial defect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSI in PEEK | Device | A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device related adverse events | Percentage of patients with the following device related adverse events:
| 0-24 months post initial implantation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Lauwers, MD | Centre Hospitalier Universitaire de Toulouse, Toulouse, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH Allgemeines Krankenhaus | Vienna | Austria | ||||
| Hôpital Erasme ULB |
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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:
| 0 months - at the study visit, which is at least 24 months after implantation |
| Brussels |
| Belgium |
| Hospital San Pablo de Coquimbo | Coquimbo | Chile |
| Hospital de Trabajador de Santiago | Santiago | Chile |
| Hospital San José | Bogotá | Colombia |
| Hospital Universitario San Ignacio | Bogotá | Colombia |
| Instituto Roosevelt | Bogotá | Colombia |
| Hospital Universitario del Valle | Santiago de Cali | Colombia |
| Hospital Clinica Biblica | Cartago | Costa Rica |
| University Hospital | Ostrava | Czechia |
| Rigshospital | Copenhagen | Denmark |
| Oulu University Hospital | Oulu | Finland |
| Centre Hospitalier Universitaire | Toulouse | France |
| Universitätsklinikum Aachen | Aachen | Germany |
| HELIOS-Klinikum Emil von Behring | Berlin | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | Germany |
| Clemenshospital Münster | Heidelberg | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | Germany |
| Hospital da Universidade | Coimbra | Portugal |
| National Neuroscience Institute | Singapore | Singapore |
| Hospital 12 de Octubre | Madrid | Spain |
| Ramon y Cajal Hospital | Madrid | Spain |
| Clinica Universitaria Navarra | Pamplona | Spain |
| Inselspital | Bern | Switzerland |
| Hôpital Cantonal Universitaire | Geneva | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland |
| Kantonsspital St- Gallen | Sankt Gallen | Switzerland |
| Universitätsspital Zürich | Zurich | Switzerland |
| Queen Victoria Hospital | East Grinstead | United Kingdom |
| The Walton Center | Liverpool | United Kingdom |