Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins|
- 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)
- An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone.
|Study Start Date:||May 2006|
|Estimated Study Completion Date:||May 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206791
|Contact: CATONNE Y, Pr.||(+33) 01 42 17 70 96|
|CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C||Not yet recruiting|
|Bordeaux, France, 33000|
|Contact: D. CHAUVEAUX, Pr|
|Principal Investigator: D. CHAUVEAUX, Pr|
|CH des Broussailes - Service de Chirurgie Orthopédique et Traumatologique||Recruiting|
|Cannes, France, 06400|
|Contact: J. TABUTIN, Dr|
|Principal Investigator: J. TABUTIN, Dr|
|CHU de Fort de France - Hôpital Pierre ZODBA-QUITMAN - Service d'Orthopédie et Traumatologie||Not yet recruiting|
|Fort de France, France, 97261|
|Contact: J. L. ROUVILAIN, Pr|
|Principal Investigator: J. L. ROUVILAIN, Pr|
|Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière||Not yet recruiting|
|Paris, France, 75013|
|Contact: CATONNE Y, Pr. (+33) 01 42 17 70 96|
|Principal Investigator: CATONNE Y, Pr.|
|Principal Investigator:||CATONNE Y, Pr.||Hôpital de la Pitié Salpétrière - 75013 PARIS - France|