STernectOmy Repair Efficiency of a Ceramic Implant

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.

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Key information

Conditions

Bones, Tumors Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limoges Hospital, Limoges, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceramic Implant

Device

The replacement of the sternum by a ceramic implant

Primary outcomes

vital capacity

Time frame: 1 day

Slow Vital Capacity (liters), forced vital capacity (liters)

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: STOIC

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Feb 17, 2016
Registry last updated: Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed