Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00206791|
Recruitment Status : Unknown
Verified October 2006 by Biomatlante.
Recruitment status was: Recruiting
First Posted : September 21, 2005
Last Update Posted : October 26, 2006
|Condition or disease||Intervention/treatment||Phase|
|Grafting, Bone||Device: MBCP-Gel (tm)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins|
|Study Start Date :||May 2006|
|Study Completion Date :||May 2008|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|