CM Asia Nail With AS2 Without AS2 （AS2 Study）

Trochanteric Fracture of Femur Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Femoral Fractures
• Hip Fractures
• Trochanteric Fracture of Femur

• NCT number: NCT03196193
• Study type: Interventional
• Source: Zimmer Biomet
• Status: Completed
• Phase: N/A
• Start date: March 21, 2017
• Completion date: April 9, 2020