Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™
The patients will be included as soon as they are implanted and follow-up for 2 years. It is observational so no specific exam is planned.
The explantation rate will be measured, that is to say the number of patients whose prosthesis will be removed (with or without any relationship with the implant or the procedure).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| craniectomy | craniectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| craniectomy | Procedure | craniectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Explantation rate after 2 years of follow-up | The main objective of the study is to measure the explantation rate after the implantation of a Custombone TM prosthesis. We will measure the number of patients whose prosthesis has an been removed, with or without any relationship with the implant or the procedure | 24 months after implantation |
Not provided
Not provided
Inclusion Criteria:
Exclusion criteria:
- Patient who does not accept to take part in the study after being informed
Not provided
Not provided
Not provided
Not provided
All patient implanted with the Custombone prosthesis
Not provided
| Name | Affiliation | Role |
|---|---|---|
| S Froelich | Hospital Lariboisiere Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Amiens | Amiens | France | ||||
| CHU Angers |
Not provided
Not provided
Not provided
Not provided
| Angers |
| France |
| CH de la cote basque | Bayonne | France |
| CHU la cavale blanche | Brest | France |
| CHU Beaujon | Clichy | France |
| CHU Henri Mondor | Créteil | France |
| CHRU Roger Salengro | Lille | France |
| CHU Lyon | Lyon | France |
| CHU Hotel Dieu | Nantes | France |
| CHU Pasteur | Nice | France |
| CHU Lariboisière | Paris | France |
| CHU La¨Pitié Salpêtrière | Paris | France |
| Hopital Maison Blanche | Reims | France |
| Hôpital Ponchaillou | Rennes | France |
| CH Saint Etienne | Saint-Etienne | France |
| CHU Hautepierre | Strasbourg | France |
| CH Bretonneau | Tours | France |
| Clinique du Tonkin | Villeurbanne | France |
| ID | Term |
|---|---|
| D003399 | Craniotomy |
| ID | Term |
|---|---|
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided