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

Sponsor

Biomatlante (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00206791

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Grafting, Bone	Device: MBCP-Gel (tm)	N/A

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

May 1, 2006

Study Completion Date :

May 1, 2008

Outcome Measures

Primary Outcome Measures

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) []

Secondary Outcome Measures

An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C	Bordeaux	France	33000
2	CH des Broussailes - Service de Chirurgie Orthopédique et Traumatologique	Cannes	France	06400
3	CHU de Fort de France - Hôpital Pierre ZODBA-QUITMAN - Service d'Orthopédie et Traumatologie	Fort de France	France	97261
4	Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière	Paris	France	75013