Clinical trial NCT00206791: Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects
Official title: Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grafting, Bone
Keywords: bone substitutes
Bone Replacement Materials
bone void filler
Grafting, Bone
Bone Cysts
Lead sponsor: Biomatlante
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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)
timeFrame: 3, 6 and 12 months
Secondary outcomes:
measure: An analysis of numeric radiographic stereotypes by grey steps will study the evolution of the density of the implant and environmental bone.
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C
city: Cannes
country: France
facility: CH des Broussailes - Service de Chirurgie Orthopédique et Traumatologique
city: Fort De France
country: France
facility: CHU de Fort de France - Hôpital Pierre ZODBA-QUITMAN - Service d'Orthopédie et Traumatologie
city: Paris
country: France
facility: Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière
Study officials:
affiliation: Hôpital de la Pitié Salpétrière - 75013 PARIS - France
name: CATONNE Y, Pr.
role: PRINCIPAL_INVESTIGATOR
References: