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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bordeaux, France, 33000
- CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C
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Cannes, France, 06400
- CH des Broussailes - Service de Chirurgie Orthopédique et Traumatologique
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Fort De France, France, 97261
- CHU de Fort de France - Hôpital Pierre ZODBA-QUITMAN - Service d'Orthopédie et Traumatologie
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Paris, France, 75013
- Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MBCPGel
|
MBCPGel 5ml
Other Names:
MBCPGel 5ML
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
Time Frame: 3, 6 and 12 months
|
3, 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone.
Time Frame: 3, 6 and 12 months
|
3, 6 and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: CATONNE Y, Pr., Hôpital de la Pitié Salpétrière - 75013 PARIS - France
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002/01/001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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