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

• Sponsor: Integra LifeSciences Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01824706
• Collaborator: (none)
• Enrollment: 110
• Locations: 18
• Actual Duration (Months): 41
• Patients Per Site: 6.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Surgery	Procedure: craniectomy

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 110 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official 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™
• Actual Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
craniectomy craniectomy	Procedure: craniectomy; craniectomy

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH Amiens	Amiens		France
2	CHU Angers	Angers		France
3	CH de la cote basque	Bayonne		France
4	CHU la cavale blanche	Brest		France
5	CHU Beaujon	Clichy		France
6	CHU Henri Mondor	Créteil		France
7	CHRU Roger Salengro	Lille		France
8	CHU Lyon	Lyon		France
9	CHU Hotel Dieu	Nantes		France
10	CHU Pasteur	Nice		France
11	CHU Lariboisière	Paris		France
12	CHU La¨Pitié Salpêtrière	Paris		France
13	Hopital Maison Blanche	Reims		France
14	Hôpital Ponchaillou	Rennes		France
15	CH Saint Etienne	Saint-Etienne		France
16	CHU Hautepierre	Strasbourg		France
17	CH Bretonneau	Tours		France
18	Clinique du Tonkin	Villeurbanne		France

Sponsors and Collaborators

• Integra LifeSciences Corporation

Investigators

• Principal Investigator: S Froelich, Hospital Lariboisiere Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Integra LifeSciences Corporation
• ClinicalTrials.gov Identifier: NCT01824706
• Other Study ID Numbers: NT-PMK-1201
• First Posted: Apr 5, 2013
• Last Update Posted: Jul 2, 2018
• Last Verified: Jun 1, 2018

• 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
• Keywords provided by Integra LifeSciences Corporation: cranial prosthesis

Study Results

No Results Posted as of Jul 2, 2018