MBCP Safety and Performance in the Osteonecrosis of Femur Head
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00289575|
Recruitment Status : Unknown
Verified March 2007 by Biomatlante.
Recruitment status was: Recruiting
First Posted : February 10, 2006
Last Update Posted : March 2, 2007
|Condition or disease||Intervention/treatment||Phase|
|Osteonecrosis||Device: MBCP||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||February 2006|
|Study Completion Date :||February 2008|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289575
|Contact: Thierry FABRE, Prfirstname.lastname@example.org|
|Contact: Dominique CHAUVEAUX, Premail@example.com|
|Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin||Recruiting|
|Bordeaux, France, 33076|
|Contact: Thierry FABRE, ¨Pr +33556795544 firstname.lastname@example.org|
|Contact: Dominique CHAUVEAUX, pr +33556795679 email@example.com|
|Principal Investigator: Thierry FABRE, Pr|
|Principal Investigator:||Thierry FABRE, Pr||University Hospital, Bordeaux|
|Study Chair:||Jacques DEMOTES-MAINARD, Pr||Clinical Research Center INSERM/Bordeaux University Hospital|