NCT03196193

CM Asia Nail With AS2 Without AS2 （AS2 Study）

Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail With Anterior Support Screw (AS2) Versus Conventional Technique

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Trochanteric Fracture of Femur

Interventions

Type	Name	Description
PROCEDURE	Open Reduction and Internal Fixation	Fractured bone fragments are reduced and stabilized by intramedullary nail.
DEVICE	ZNN CM Asia	Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.
DEVICE	Anterior Support Screw	Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.

Timeline

• Start date: 2017-03-21
• Primary completion: 2020-04-02
• Completion: 2020-04-09
• First posted: 2017-06-22
• Last updated: 2020-09-29
• Results posted: 2020-09-29

Locations

12 sites across 1 country: Japan

Regulatory

• FDA-regulated device study