NCT00289575

MBCP Safety and Performance in the Osteonecrosis of Femur Head

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.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (planned)
• Sponsor: Biomatlante · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteonecrosis

Interventions

Type	Name	Description
DEVICE	MBCP

Timeline

• Start date: 2006-02-01
• Completion: 2008-02-01
• First posted: 2006-02-10
• Last updated: 2007-03-02

Locations

1 site across 1 country: France