MBCP Safety and Performance in the Osteonecrosis of Femur Head
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Biopsy of Femur Head.|
- Infection and inflammation of the drilled area (blood and clinical assessment).
- Adverse events.
- Pain (Analogic Visual Scale)
- Hip function
- Bone reconstruction evaluation through scanner and radiography
|Study Start Date:||February 2006|
|Estimated Study Completion Date:||February 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289575
|Contact: Thierry FABRE, Premail@example.com|
|Contact: Dominique CHAUVEAUX, Prfirstname.lastname@example.org|
|Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin||Recruiting|
|Bordeaux, France, 33076|
|Contact: Thierry FABRE, ¨Pr +33556795544 email@example.com|
|Contact: Dominique CHAUVEAUX, pr +33556795679 firstname.lastname@example.org|
|Principal Investigator: Thierry FABRE, Pr|
|Principal Investigator:||Thierry FABRE, Pr||Bordeaux University Hospital|
|Study Chair:||Jacques DEMOTES-MAINARD, Pr||Clinical Research Center INSERM/Bordeaux University Hospital|