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| Name | Class |
|---|---|
| CIC Bordeaux | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBCP | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Infection and inflammation of the drilled area (blood and clinical assessment). | ||
| Adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (Analogic Visual Scale) | ||
| Hip function | ||
| Bone reconstruction evaluation through scanner and radiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thierry FABRE, Pr | Contact | +33556795544 | thierry.fabre@chu-bordeaux.fr | |
| Dominique CHAUVEAUX, Pr | Contact | +33556795679 | dominique.chauveaux@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thierry FABRE, Pr | University Hospital, Bordeaux | Principal Investigator |
| Jacques DEMOTES-MAINARD, Pr | Clinical Research Center INSERM/Bordeaux University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin | Recruiting | Bordeaux | 33076 | France |
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| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |