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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
CIC Bordeaux
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Osteonecrosis Device: MBCP Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : February 2006
Estimated Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis
U.S. FDA Resources

Primary Outcome Measures :
  1. Infection and inflammation of the drilled area (blood and clinical assessment).
  2. Adverse events.

Secondary Outcome Measures :
  1. Pain (Analogic Visual Scale)
  2. Hip function
  3. Bone reconstruction evaluation through scanner and radiography

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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, Pr +33556795544 thierry.fabre@chu-bordeaux.fr
Contact: Dominique CHAUVEAUX, Pr +33556795679 dominique.chauveaux@chu-bordeaux.fr

Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin Recruiting
Bordeaux, France, 33076
Contact: Thierry FABRE, ¨Pr    +33556795544    thierry.fabre@chu-bordeaux.fr   
Contact: Dominique CHAUVEAUX, pr    +33556795679    dominique.chauveaux@chu-bordeaux.fr   
Principal Investigator: Thierry FABRE, Pr         
Sponsors and Collaborators
CIC Bordeaux
Principal Investigator: Thierry FABRE, Pr University Hospital, Bordeaux
Study Chair: Jacques DEMOTES-MAINARD, Pr Clinical Research Center INSERM/Bordeaux University Hospital

ClinicalTrials.gov Identifier: NCT00289575     History of Changes
Other Study ID Numbers: 63
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: March 2, 2007
Last Verified: March 2007

Keywords provided by Biomatlante:
Femur head aseptic osteonecrosis
Bone reconstruction
Macroporous biphasic calcium phosphate granules

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases
Pathologic Processes