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

Grafting, Bone Clinical Trial

Official title:

Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00206791
• Other study ID #: 2002/01/001
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: October 25, 2006
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: October 2006
• Source: Biomatlante
• Contact: CATONNE Y, Pr.
• Phone: (+33) 01 42 17 70 96
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Grafting, Bone

Intervention

Device:
• MBCP-Gel (tm)

Locations

Country	Name	City	State
France	CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C	Bordeaux
France	CH des Broussailes - Service de Chirurgie Orthopédique et Traumatologique	Cannes
France	CHU de Fort de France - Hôpital Pierre ZODBA-QUITMAN - Service d'Orthopédie et Traumatologie	Fort de France
France	Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Biomatlante

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone.