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Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant

NCT01824706 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2018-07-02

No results posted yet for this study

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

  • Surgery

Interventions

PROCEDURE

craniectomy

craniectomy

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • S Froelich · Hospital Lariboisiere Paris

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-01
Primary Completion
2016-05-01
Completion
2016-05-01
FDA Device
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01824706 on ClinicalTrials.gov