Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant
CUSTOMBONE
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™
1 other identifier
observational
110
1 country
18
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2012
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 25, 2013
CompletedFirst Posted
Study publicly available on registry
April 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJuly 2, 2018
June 1, 2018
3.4 years
March 25, 2013
June 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
craniectomy
craniectomy
Interventions
Eligibility Criteria
All patient implanted with the Custombone prosthesis
You may qualify if:
- Patient planning to have a cranioplasty and be implanted with the Custombone™ medical device
- Patient who agrees to take part in the study, or agreement of a representative of the patient in case of patient inability, after being informed by the investigator and having received an information letter
You may not qualify if:
- \- Patient who does not accept to take part in the study after being informed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
CH Amiens
Amiens, France
CHU Angers
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
S Froelich
Hospital Lariboisiere Paris
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2013
First Posted
April 5, 2013
Study Start
December 1, 2012
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
July 2, 2018
Record last verified: 2018-06