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
Recruitment status was Recruiting
Sponsor:
Biomatlante
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 9, 2006 | ||||||||
| Last Updated Date | March 1, 2007 | ||||||||
| Start Date ICMJE | February 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00289575 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | MBCP Safety and Performance in the Osteonecrosis of Femur Head | ||||||||
| Official Title ICMJE | 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. | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Osteonecrosis | ||||||||
| Intervention ICMJE | Device: MBCP | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 12 | ||||||||
| Completion Date | February 2008 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00289575 | ||||||||
| Other Study ID Numbers ICMJE | 63 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Biomatlante | ||||||||
| Collaborators ICMJE | CIC Bordeaux | ||||||||
| Investigators ICMJE |
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| Information Provided By | Biomatlante | ||||||||
| Verification Date | March 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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