Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 9:26 PM
Study NCT ID:
NCT04577261
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2020-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FNS (FEMORAL NECK SYSTEM) Study
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
A Prospective Study To Evaluate The FEMORAL NECK SYSTEM (FNS) In The Treatment Of INTRA-CAPSULAR FEMORAL Neck Fractures
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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:
FNS
Brief Summary:
A post-market, prospective study to evaluate the reoperation rate of displaced and nondisplaced femoral neck fractures treated with the Femoral Neck System (FNS)™
Detailed Description:
To evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the Femoral Neck System (FNS)™ at one year post-operation. The Femoral Neck System (FNS)™ represents a new generation of implants designed to improve outcomes in the treatment of femoral neck fractures. These implants offer a fixed angle construct and all of its mechanical advantages with regards to neutralizing shear and providing stability while not exerting a rotational malreduction force on the fracture. The FNS system has been shown to compare favorably to traditional fixed angle constructs in a cadaveric model
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: