Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409799
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2006-12-08
Brief Title:
Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting
Sponsor:
Kuros Biosurgery AG
Organization:
Kuros Biosurgery AG
Study Overview
Official Title:
A Phase 2 Randomized Controlled Open-label Dose-blinded Multi-center Dose-finding Study of the Safety and Efficacy of I-0401 in the Treatment of Patients With Fractures of the Tibial Plateau Requiring Grafting
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
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:
For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident The void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated I 0401 is a new bone graft substitute that has shown capacities to promote bone-healing This study will test the safety and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring grafting
Detailed Description:
None
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