STernectOmy Repair Efficiency of a Ceramic Implant (STOIC)

August 8, 2019 updated by: University Hospital, Limoges

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

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
      • Limoges, France, 87 042
        • Limoges hospital
      • Nice, France
        • Saint George clinic
      • Reims, France
        • Reims University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sternum by a ceramic implant
The replacement of the sternum by a ceramic implant
Device: Ceramic Implant
The replacement of the sternum by a ceramic implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vital capacity
Time Frame: 1 day
Slow Vital Capacity (liters), forced vital capacity (liters)
1 day

Collaborators and Investigators

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

Sponsor

University Hospital, Limoges

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

March 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • I15032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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