MBCP Safety and Performance in the Osteonecrosis of Femur Head
Phase 2
- Conditions
- Osteonecrosis
- Registration Number
- NCT00289575
- Lead Sponsor
- Biomatlante
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- femur head osteonecrosis (1 to 2 level in ARCO scale)
- signed informed consent
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Infection and inflammation of the drilled area (blood and clinical assessment). Adverse events.
- Secondary Outcome Measures
Name Time Method Pain (Analogic Visual Scale) Hip function Bone reconstruction evaluation through scanner and radiography
Trial Locations
- Locations (1)
Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin
🇫🇷Bordeaux, France