Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT01693367
Status:
TERMINATED
Last Update Posted:
2020-08-13
First Post:
2012-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
Sponsor:
AO Innovation Translation Center
Organization:
Study Overview
Official Title:
A Multi-Center Randomized Controlled Pilot Study of Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The medical device has been withdrawn from the market due to technical issues.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: