Status:
UNKNOWN
MBCP Safety and Performance in the Osteonecrosis of Femur Head
Lead Sponsor:
Biomatlante
Collaborating Sponsors:
CIC Bordeaux
Conditions:
Osteonecrosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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 th...
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...
Eligibility Criteria
Inclusion
- femur head osteonecrosis (1 to 2 level in ARCO scale)
- signed informed consent
Exclusion
- primary bone infection
- femur head sphericity loss
- cancer, diabetes, tuberculosis previous history
- HIV, Hepatitis B, Hepatitis C infection
- drepanocytosis
- current corticotherapy
- current immunosuppressive therapy
- innate or acquired immune deficience
- pregnancy or lack of efficient contraception
- current participation in an other study
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00289575
Start Date
February 1 2006
End Date
February 1 2008
Last Update
March 2 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin
Bordeaux, France, 33076