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

June 29, 2018 updated by: Integra LifeSciences Corporation

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™

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CH Amiens
      • Angers, France
        • Chu Angers
      • Bayonne, France
        • CH de la Côte Basque
      • Brest, France
        • CHU La Cavale Blanche
      • Clichy, France
        • CHU Beaujon
      • Créteil, France
        • CHU Henri Mondor
      • Lille, France
        • CHRU Roger Salengro
      • Lyon, France
        • CHU LYON
      • Nantes, France
        • Chu Hotel Dieu
      • Nice, France
        • Chu Pasteur
      • Paris, France
        • CHU Lariboisière
      • Paris, France
        • CHU La¨Pitié Salpêtrière
      • Reims, France
        • Hôpital Maison Blanche
      • Rennes, France
        • Hôpital Ponchaillou
      • Saint-Etienne, France
        • Ch Saint Etienne
      • Strasbourg, France
        • CHU HautePierre
      • Tours, France
        • Ch Bretonneau
      • Villeurbanne, France
        • Clinique du Tonkin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patient implanted with the Custombone prosthesis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
craniectomy
Procedure: craniectomy
craniectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integra LifeSciences Corporation

Investigators

  • Principal Investigator: S Froelich, Hospital Lariboisiere Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NT-PMK-1201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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