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Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects

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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
Sponsor:
Information provided by:
Biomatlante

September 12, 2005
September 21, 2005
October 26, 2006
May 2006
Not Provided
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)
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).
Complete list of historical versions of study NCT00206791 on ClinicalTrials.gov Archive Site
An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone.
Same as current
Not Provided
Not Provided
 
Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects
Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins
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.

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.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Grafting, Bone
Device: MBCP-Gel (tm)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
12
Same as current
May 2008
Not Provided

Inclusion Criteria:

  • Medium osseous defects (inferior to 20 cc) without articular communication
  • Patients without a personal medical history of bone infection, cancer, diabetes, tuberculosis, and in general, any pathology which could interfere with the results of the study or expose the patient to additional risk
  • Patients without drepanocytosis, or congenital or acquired immunizing deficit
  • Patients who have the benefit of a social security system, a previous medical exam and who were informed and gave free consent about this study

Exclusion Criteria:

  • Proven nicotinism and alcoholism
  • Pregnant or nursing women
  • Patients who received another study drug or another study device in the past 3 months or patients who will be included in another clinical study
  • If postoperative follow-up for a patient is considered to be random by the investigator, he/she should not be included
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00206791
2002/01/001
Not Provided
Not Provided
Not Provided
Not Provided
Biomatlante
Not Provided
Principal Investigator: CATONNE Y, Pr. Hôpital de la Pitié Salpétrière - 75013 PARIS - France
Biomatlante
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP