CM Asia Nail With AS2 Without AS2 （AS2 Study）

Zimmer Biomet

Status: Completed

Conditions: Trochanteric Fracture of Femur

Treatments: Procedure: Open Reduction and Internal Fixation; Device: ZNN CM Asia; Device: Anterior Support Screw

Study type: Interventional

Funder types: Industry

Identifiers

NCT03196193

T.CR.I.AP.16.4

Details and patient eligibility

About

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.

Full 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

Enrollment: 240 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria.

• Eligible for intramedullary nailing.
• Fracture type is classified as 3-partB or 4-part fracture in 3D-CT (Three Dimensional Computed Tomography) classification (Nakano), and combination with a subtype P in lateral classification (Ikuta) at preoperative CT (Computed Tomography) assessment.(In the case of classified in radiograph (X-ray) at preoperative: Classified as Type 4 or Type 5 in Jensen classification, and combination of subtype P in lateral classification (Ikuta))
• Japanese Male or female
• > 20 years of age
• Primary closed intertrochanteric fracture of the femur
• Subjects willing to return for follow-up evaluations.

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study.

• Patient who cannot take CT image within 3 days and 2-3weeks after surgery.
• Uncooperative patient or patient with neurologic disorders who are incapable of following directions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

ZNN CM Asia with AS2 technique

Experimental group

Description:

Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail. Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw).

Treatment:

Procedure: Open Reduction and Internal Fixation

Device: Anterior Support Screw

Device: ZNN CM Asia

ZNN CM Asia without AS2 technique

Active Comparator group

Description:

Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.

Treatment:

Procedure: Open Reduction and Internal Fixation

Device: ZNN CM Asia