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

Completed

• Conditions: Surgery
• Interventions: Procedure: craniectomy

• Registration Number: NCT01824706
• Lead Sponsor: Integra LifeSciences Corporation

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-01
• Study First Submitted: 2013-03-25
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-05
• Primary Completion: 2016-05-01
• Study Completion: 2016-05-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
craniectomy	craniectomy	craniectomy

Primary Outcome Measures

Name	Time	Method
Explantation rate after 2 years of follow-up	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

Trial Locations

Locations (18)

CHU Henri Mondor; 🇫🇷 Créteil, France

CHU Angers; 🇫🇷 Angers, France

CH de la cote basque; 🇫🇷 Bayonne, France

CHU Beaujon; 🇫🇷 Clichy, France

CHU la cavale blanche; 🇫🇷 Brest, France

CHU Lyon; 🇫🇷 Lyon, France

CHRU Roger Salengro; 🇫🇷 Lille, France

CHU Hotel Dieu; 🇫🇷 Nantes, France

CHU La¨Pitié Salpêtrière; 🇫🇷 Paris, France

Hopital Maison Blanche; 🇫🇷 Reims, France

CHU Lariboisière; 🇫🇷 Paris, France

CHU Pasteur; 🇫🇷 Nice, France

Hôpital Ponchaillou; 🇫🇷 Rennes, France

CH Saint Etienne; 🇫🇷 Saint-Etienne, France

CHU Hautepierre; 🇫🇷 Strasbourg, France

CH Bretonneau; 🇫🇷 Tours, France

Clinique du Tonkin; 🇫🇷 Villeurbanne, France

CH Amiens; 🇫🇷 Amiens, France