- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00289575
MBCP Safety and Performance in the Osteonecrosis of Femur Head
March 1, 2007 updated by: Biomatlante
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.
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 Overview
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
Enrollment
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Thierry FABRE, Pr
- Phone Number: +33556795544
- Email: thierry.fabre@chu-bordeaux.fr
Study Contact Backup
- Name: Dominique CHAUVEAUX, pr
- Phone Number: +33556795679
- Email: dominique.chauveaux@chu-bordeaux.fr
Study Locations
-
-
-
Bordeaux, France, 33076
- Recruiting
- Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin
-
Contact:
- Dominique CHAUVEAUX, pr
- Phone Number: +33556795679
- Email: dominique.chauveaux@chu-bordeaux.fr
-
Contact:
- Thierry FABRE, ¨Pr
- Phone Number: +33556795544
- Email: thierry.fabre@chu-bordeaux.fr
-
Principal Investigator:
- Thierry FABRE, Pr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Adverse events.
|
Infection and inflammation of the drilled area (blood and clinical assessment).
|
Secondary Outcome Measures
Outcome Measure |
---|
Pain (Analogic Visual Scale)
|
Hip function
|
Bone reconstruction evaluation through scanner and radiography
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thierry FABRE, Pr, University Hospital, Bordeaux
- Study Chair: Jacques DEMOTES-MAINARD, Pr, Clinical Research Center INSERM/Bordeaux University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Study Completion
February 1, 2008
Study Registration Dates
First Submitted
February 9, 2006
First Submitted That Met QC Criteria
February 9, 2006
First Posted (Estimate)
February 10, 2006
Study Record Updates
Last Update Posted (Estimate)
March 2, 2007
Last Update Submitted That Met QC Criteria
March 1, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 63
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteonecrosis
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McGill University Health Centre/Research Institute...UnknownOsteonecrosis of Femoral Head | Osteonecrosis; Aseptic, IdiopathicCanada
-
Fundació d'investigació Sanitària de les Illes...RecruitingOsteonecrosis of the Jaw, Bisphosphonate Induced | Osteonecrosis of the Jaw, Bisphosphonate RelatedSpain
-
AmgenCompletedOsteonecrosis of the JawFrance, Germany, Italy, United States, Belgium, United Kingdom, Spain, Greece, Canada, Denmark, Finland
-
Centre Hospitalier Sud FrancilienTerminatedOsteonecrosis Due to Drugs, JawFrance
-
Shiraz University of Medical SciencesShahid Beheshti University of Medical SciencesCompletedOsteonecrosis Due to Drugs, Jaw
-
Red de Terapia CelularFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia and other collaboratorsUnknown
-
Kaohsiung Medical University Chung-Ho Memorial...National Taiwan University Hospital; Merck Sharp & Dohme LLC; National Cheng-Kung...UnknownNon-Traumatic OsteonecrosisTaiwan
-
University of PalermoCompletedMEDICATION RELATED OSTEONECROSIS OF THE JAWItaly
-
University of PalermoSuspendedMEDICATION RELATED OSTEONECROSIS OF THE JAWItaly
-
Shengjing HospitalCompletedOsteonecrosis of Femoral Head
Clinical Trials on MBCP
-
University of Wisconsin, MadisonSuspended
-
Karolinska InstitutetCompletedStress, Psychological | Depression, Postpartum | Stress, Physiological | Parent-Child Relations
-
Advanced Medical Solutions Ltd.Not yet recruitingTrauma Injury | Orthopedic Disorder | Extremity Injury
-
National Taipei University of Nursing and Health...UnknownStress, Psychological | Pregnancy Related
-
Nantes University HospitalUnknown
-
BiomatlanteUnknown
-
Baxter Healthcare CorporationCompletedSinus Implant ReconstructionGermany