The purpose of this non comparative study is to test for the first time the bioactivity of a new calcium phosphate biomaterial “ready to use” in fillings of little losses of osseous substance from various origins (traumatic, benign tumoral...).

Condition	Intervention
Bone Defect	Device: MBCP-Gel(TM)

Further Study Details: 

Primary Outcomes: 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).
Secondary Outcomes: An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone.
Expected Total Enrollment:  12

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 osteoconductor 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.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Medium osseous defects (inferior to 20 cc) without articular communication
• Patient which have the benefit of social security system
• Patient which had a previous medical exam
• Patient which was informed and gave a free and consent

Exclusion Criteria:

• Patient without personal medical history of bone infection, cancer; diabetes, tuberculosis and generally of any pathology which could interfere with the results of the study or expose the patient at the additional risk.
• Patient without drepanocytosis, congenital or acquired immunizing deficit
• If women, their should not be pregnant or nursing
• Patient which received an other study drug / device since 3 months or which is yet include in an other clinical study Proven nicotinism and alcoholism
• If postoperative follow-up for a patient is considered to be random by the investigator, he should not be including.

Please refer to this study by ClinicalTrials.gov identifier  NCT00206791

CATONNE Y, Pr.      (+33) 01 42 17 70 96 

France
      Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière, Paris,  75013,  France

Study chairs or principal investigators

CATONNE Y, Pr.,  Principal Investigator,  Hôpital de la Pitié Salpétrière - 75013 PARIS - France   

Study ID Numbers:  2002/01/001
Last Updated:  September 20, 2005
Record first received:  September 12, 2005
ClinicalTrials.gov Identifier:  NCT00206791
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-27