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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Biomatlante.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biomatlante
ClinicalTrials.gov Identifier:
NCT00206791
First received: September 12, 2005
Last updated: October 25, 2006
Last verified: October 2006
  Purpose

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 Intervention
Grafting, Bone
Device: MBCP-Gel (tm)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biomatlante:

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.

Estimated Enrollment: 12
Study Start Date: May 2006
Estimated Study Completion Date: May 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206791

Contacts
Contact: CATONNE Y, Pr. (+33) 01 42 17 70 96

Locations
France
CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C Not yet recruiting
Bordeaux, France, 33000
Contact: D. CHAUVEAUX, Pr         
Principal Investigator: D. CHAUVEAUX, Pr         
CH des Broussailes - Service de Chirurgie Orthopédique et Traumatologique Recruiting
Cannes, France, 06400
Contact: J. TABUTIN, Dr         
Principal Investigator: J. TABUTIN, Dr         
CHU de Fort de France - Hôpital Pierre ZODBA-QUITMAN - Service d'Orthopédie et Traumatologie Not yet recruiting
Fort de France, France, 97261
Contact: J. L. ROUVILAIN, Pr         
Principal Investigator: J. L. ROUVILAIN, Pr         
Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière Not yet recruiting
Paris, France, 75013
Contact: CATONNE Y, Pr.    (+33) 01 42 17 70 96      
Principal Investigator: CATONNE Y, Pr.         
Sponsors and Collaborators
Biomatlante
Investigators
Principal Investigator: CATONNE Y, Pr. Hôpital de la Pitié Salpétrière - 75013 PARIS - France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00206791     History of Changes
Other Study ID Numbers: 2002/01/001
Study First Received: September 12, 2005
Last Updated: October 25, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Biomatlante:
bone substitutes
Bone Replacement Materials
bone void filler
Grafting, Bone
Bone Cysts

ClinicalTrials.gov processed this record on April 17, 2014