CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 240 enrolled
Drug / intervention
Open Reduction and Internal Fixation +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03196193
NCT03196193N/ACompleted
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Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail With Anterior Support Screw (AS2) Versus Conventional Technique

Zimmer Biomet·interventional·Posted Jun 22, 2017·Updated Sep 29, 2020

In Brief

A clinical study evaluating Open Reduction and Internal Fixation, ZNN CM Asia, and 1 other intervention for Trochanteric Fracture of Femur. Completed, enrolled 240 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrochanteric Fracture of Femur
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 22, 2017
Enrollment StartMar 21, 2017
Primary CompletionApr 2, 2020
Study CompletionApr 9, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.0 years ago

Interventions

Open Reduction and Internal Fixationprocedure

Fractured bone fragments are reduced and stabilized by intramedullary nail.

ZNN CM Asiadevice

Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.

Anterior Support Screwdevice

Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.