Clinical Trial: Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects
Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Biomatlante
Current Primary Outcome: Presence or absence of an edging to radiolucent on the radiographic stereotypes between the biomaterial and the osseous walls of the osseous defect at different times (3, 6 and 12 months after surgery)
Original Primary Outcome: Presence or absence of an edging to radioclair on the radiographic stereotypes between the biomaterial and the osseous walls of the osseous defect at different time (3, 6 and 12 months after surgery).
Current Secondary Outcome: An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone.
Original Secondary Outcome: Same as current
Information By: Biomatlante
Dates:
Date Received: September 12, 2005
Date Started: May 2006
Date Completion: May 2008
Last Updated: October 25, 2006
Last Verified: October 2006
