Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00289575
Status:
UNKNOWN
Last Update Posted:
2007-03-02
First Post:
2006-02-09
Brief Title:
MBCP Safety and Performance in the Osteonecrosis of Femur Head
Sponsor:
Biomatlante
Organization:
Biomatlante
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None