MBCP-Gel (tm)
DeviceMBCPGel 5ml
Other names: injectable resorbable biphasic calcium phosphate
NCT Number: NCT00206791
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C, Bordeaux, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MBCPGel 5ml
Other names: injectable resorbable biphasic calcium phosphate
MBCPGel 5ML
Other names: Injectable biphasic calium phosphate
Time frame: 3, 6 and 12 months
Time frame: 3, 6 and 12 months
Biomatlante
Industry
Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins
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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.
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