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STernectOmy Repair Efficiency of a Ceramic Implant (STOIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683590
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Bones, Tumors Device: Ceramic Implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: STernectOmy Repair Efficiency of a Ceramic Implant
Study Start Date : March 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : August 2019

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




Primary Outcome Measures :
  1. vital capacity [ Time Frame: 1 day ]
    Slow Vital Capacity (liters), forced vital capacity (liters)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683590


Locations
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France
Limoges Hospital
Limoges, France, 87 042
Saint George clinic
Nice, France
Reims university hospital
Reims, France
Sponsors and Collaborators
University Hospital, Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02683590    
Other Study ID Numbers: I15032
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Limoges:
Sternectomie
Ceramic Implant
Bones Tumors