CompletedNot Applicable

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

France3 participantsStarted 2006-05

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT00206791

SponsorBiomatlante

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-04

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