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™

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgery

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Amiens, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Craniectomy

Procedure

craniectomy

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

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

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™

Acronym: CUSTOMBONE

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Apr 5, 2013
Registry last updated: Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed