Trials / Completed
CompletedNCT01824706
Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant
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™
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 110 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | craniectomy | craniectomy |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2013-04-05
- Last updated
- 2018-07-02
Locations
18 sites across 1 country: France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01824706. Inclusion in this directory is not an endorsement.