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MBCP Safety and Performance in the Osteonecrosis of Femur Head

Osteonecrosis Clinical Trial

Official title:
Evaluation of Safety and Performance of Macroporous Biphasic Calcium Phosphate Granules Combined With Cellulosic-Derived Gel, in Filling Bones Gap After Aseptic Osteonecrosis Biopsy of Femur Head.

Clinical Trial Summary

The aim of this pilot study is to evaluate MBCP performance in bone regeneration after osteonecrosis biopsy of the femur head. This technic may prevent the neck of the femur bone weakness following the healthy area drilling, thanks to a bone reconstruction at the expense of the biomaterial.

Clinical Trial Description

Twelve patients will be enrolled in this study and evaluation of infection and inflammation of the drilled area, pain and hip function will be assessed during a one year follow up. Bone reconstruction will be evaluated with scanner and radiography. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00289575
Study type Interventional
Source Biomatlante
Contact Thierry FABRE, Pr
Phone +33556795544
Email thierry.fabre@chu-bordeaux.fr
Status Recruiting
Phase Phase 2
Start date February 2006
Completion date February 2008
View Details
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