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STernectOmy Repair Efficiency of a Ceramic Implant (STOIC)

U

University of Limoges (UL)

Status

Completed

Conditions

Bones, Tumors

Treatments

Device: Ceramic Implant

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

sternum by a ceramic implant
Experimental group
Description:
The replacement of the sternum by a ceramic implant
Treatment:
Device: Ceramic Implant

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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