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™
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Surgery
- Sponsor
- Integra LifeSciences Corporation
- Enrollment
- 110
- Locations
- 18
- Primary Endpoint
- Explantation rate after 2 years of follow-up
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
Eligibility Criteria
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 Criteria
- Not provided
Outcomes
Primary Outcomes
Explantation rate after 2 years of follow-up
Time Frame: 24 months after implantation
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