Status:
COMPLETED
Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Surgery
Eligibility:
All Genders
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 wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion criteria:
- \- Patient who does not accept to take part in the study after being informed
Exclusion
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01824706
Start Date
December 1 2012
End Date
May 1 2016
Last Update
July 2 2018
Active Locations (18)
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1
CH Amiens
Amiens, France
2
CHU Angers
Angers, France
3
CH de la cote basque
Bayonne, France
4
CHU la cavale blanche
Brest, France