STernectOmy Repair Efficiency of a Ceramic Implant

NCT ID: NCT02683590

Last Updated: 2019-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-08-31

Brief Summary

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For the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. The use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation, limiting the risk of infection and rejection.

Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic implant on the respiratory capacity at 3 months post surgery.

Detailed Description

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Conditions

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Bones, Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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sternum by a ceramic implant

The replacement of the sternum by a ceramic implant

Group Type EXPERIMENTAL

Ceramic Implant

Intervention Type DEVICE

The replacement of the sternum by a ceramic implant

Interventions

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Ceramic Implant

The replacement of the sternum by a ceramic implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient major
* Having a replacement indicating the sternum (or a part of the sternum)
* With an expected life of over one year, estimated by the principal investigator
* Written consent of the patient

Exclusion Criteria

* People under safeguard justice,
* Patient under guardianship,
* Patient pregnant or breastfeeding,
* Topic attending another search including a period of exclusion still going to run-in
* Contraindication to general anesthesia
* Of alumina allergy antecedent
* Recent infectious disease unsupported
* BMI\> 40
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Limoges Hospital

Limoges, , France

Site Status

Saint George clinic

Nice, , France

Site Status

Reims university hospital

Reims, , France

Site Status

Countries

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France

Other Identifiers

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I15032

Identifier Type: -

Identifier Source: org_study_id

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