Clinical Trial: MBCP Safety and Performance in the Osteonecrosis of Femur Head
Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional
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
Brief 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 Summary: 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.
Sponsor: Biomatlante
Current Primary Outcome:
- Infection and inflammation of the drilled area (blood and clinical assessment).
- Adverse events.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pain (Analogic Visual Scale)
- Hip function
- Bone reconstruction evaluation through scanner and radiography
Original Secondary Outcome: Same as current
Information By: Biomatlante
Dates:
Date Received: February 9, 2006
Date Started: February 2006
Date Completion: February 2008
Last Updated: March 1, 2007
Last Verified: March 2007
