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Completed

NCT Number: NCT00206791

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBCP-Gel (tm)

Device

MBCPGel 5ml

Other names: injectable resorbable biphasic calcium phosphate

MBCP Gel

Device

MBCPGel 5ML

Other names: Injectable biphasic calium phosphate

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Biomatlante

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 21, 2005
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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