Osteonecrosis
Conditions
Keywords
Femur head aseptic osteonecrosis, Bone reconstruction, Macroporous biphasic calcium phosphate granules
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.
Interventions
DEVICEMBCP
Sponsors
CIC Bordeaux
Biomatlante
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infection and inflammation of the drilled area (blood and clinical assessment). | — |
| Adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone reconstruction evaluation through scanner and radiography | — |
| Pain (Analogic Visual Scale) | — |
| Hip function | — |
Countries
France
Contacts
Primary ContactThierry FABRE, Pr
Backup ContactDominique CHAUVEAUX, Pr
Outcome results
None listed