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

Integra LifeSciences

Status

Completed

Conditions

Surgery

Treatments

Procedure: craniectomy

Study type

Observational

Funder types

Industry

Identifiers

NCT01824706

NT-PMK-1201

Details and patient eligibility

About

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).

Enrollment

110 patients

Sex

All

Volunteers

No Healthy Volunteers

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