Grafting, Bone Clinical Trial
Official title:
Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins
The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new “ready to use” calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as traumatic and benign tumoral causes.
A lot of osseous substitution products were already used to fill osseous defects in order to
prevent losses of osseous that are envisaged and so prejudicial.
Synthetic calcium phosphate ceramics (particularly granulated forms) already has shown their
osteoconduction potential in human at different sites. But it is difficult to put these
granules in very little place.
The injectable form of calcium phosphate granules “ready to use” is easier to be used and
allow a diminution of the risk of infection during surgery, and permit homogeneity of the
biomaterial.
Injectable form of calcium phosphate granules did already has shown his biocompatibility and
biofunctionality in animals.
The purpose of this study is to study the biocompatibility and biofunctionality of this
biomaterial in his injectable form in fillings of little losses of osseous substance from
various origins were no charge will act to the biomaterial.
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Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment