Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206037
Status:
TERMINATED
Last Update Posted:
2007-11-20
First Post:
2005-09-14
Brief Title:
Open Wedge High Tibia Osteotomy
Sponsor:
AO Clinical Investigation and Publishing Documentation
Organization:
AO Innovation Translation Center
Study Overview
Official Title:
Comparison of Open Wedge High Tibia Osteotomy Surgeries Using Colloss E and Tomofix and Tomofix Only Regarding the Bone Healing
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis showed significant results thus study was 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 RCT is to show that in a patient group receiving COLLOSS E combined with TomoFix for medical open wedge high tibial osteotomy the onset of bone healing is earlier in time compared to patients receiving TomoFix without COLLOSS E
Detailed Description:
The healing effect should be demonstrated by using MRI pictures during the entire FUs in order to demonstrate the differences if COLLOSS E is applied or not
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