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
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | May 2008 |
Est. primary completion date | |
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 |
Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Biomatlante |
France,
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. |