Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 2:44 AM
Study NCT ID:
NCT03196193
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2017-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CM Asia Nail With AS2 Without AS2 （AS2 Study）
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail With Anterior Support Screw (AS2) Versus Conventional Technique
Status:
COMPLETED
Status Verified Date:
2020-09
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:
The purpose of this study is to compare reduction positon maintenance rate at 3 weeks post-operatively between patients operated with Anterior Support Screw (AS2) and without AS2 technique in RCT setting. Total 240 cases(each arm 120 cases) will be enrolled at maximum 15sites, total study duration is 22months.
Detailed Description:
Objective： To compare fracture reduction maintenance rate at 2-3weeks post-operatively between patients operated with AS2 (investigational group) and patients operated without AS2 (Control group) using same implant system (ZNN CM Asia, Zimmer Biomet).
Endpoint： Primary： The rate of reduction position maintenance at 2-3 weeks post-operatively. Secondary： Surgery time / fracture type / postoperative reduction position / CT assessment / Safety information
Endpoint： Primary： The rate of reduction position maintenance at 2-3 weeks post-operatively. Secondary： Surgery time / fracture type / postoperative reduction position / CT assessment / Safety information
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: