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MBCP Safety and Performance in the Osteonecrosis of Femur Head

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Biomatlante.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289575
First Posted: February 10, 2006
Last Update Posted: March 2, 2007
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.
Collaborator:
CIC Bordeaux
Information provided by:
Biomatlante
  Purpose
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 Intervention Phase
Osteonecrosis Device: MBCP Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Biomatlante:

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

Secondary Outcome Measures:
  • Pain (Analogic Visual Scale)
  • Hip function
  • Bone reconstruction evaluation through scanner and radiography

Estimated Enrollment: 12
Study Start Date: February 2006
Estimated Study Completion Date: February 2008
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.
  Eligibility

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
Criteria

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
  Contacts and Locations
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


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

Locations
France
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
Biomatlante
CIC Bordeaux
Investigators
Principal Investigator: Thierry FABRE, Pr University Hospital, Bordeaux
Study Chair: Jacques DEMOTES-MAINARD, Pr Clinical Research Center INSERM/Bordeaux University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00289575     History of Changes
Other Study ID Numbers: 63
First Submitted: February 9, 2006
First Posted: February 10, 2006
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:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes