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CM Asia Nail With AS2 Without AS2 （AS2 Study）

NCT03196193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-09-29

Study results available
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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.

Conditions

  • Trochanteric Fracture of Femur

Interventions

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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Takashi Maehara, MD, Ph. D · Kagawa Rosai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-21
Primary Completion
2020-04-02
Completion
2020-04-09
FDA Device
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03196193 on ClinicalTrials.gov