MBCP Safety and Performance in the Osteonecrosis of Femur Head

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Biomatlante.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
CIC Bordeaux
Information provided by:
Biomatlante
ClinicalTrials.gov Identifier:
NCT00289575
First received: February 9, 2006
Last updated: March 1, 2007
Last verified: March 2007
  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
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.

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Bordeaux University Hospital
Study Chair: Jacques DEMOTES-MAINARD, Pr Clinical Research Center INSERM/Bordeaux University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00289575     History of Changes
Other Study ID Numbers: 63
Study First Received: February 9, 2006
Last Updated: March 1, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 22, 2014