STernectOmy Repair Efficiency of a Ceramic Implant

Bones, Tumors Clinical Trial

— STOIC  

Official title:

STernectOmy Repair Efficiency of a Ceramic Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683590
• Other study ID #: I15032
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 2019

Study information

• Verified date: January 2017
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bones, Tumors

Intervention

Device:
• Ceramic Implant
The replacement of the sternum by a ceramic implant

Locations

Country	Name	City	State
France	Limoges Hospital	Limoges
France	Saint George clinic	Nice
France	Reims university hospital	Reims

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vital capacity	Slow Vital Capacity (liters), forced vital capacity (liters)	1 day