CM Asia Nail With AS2 Without AS2 （AS2 Study）

Not Applicable

Completed

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

Brief 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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
ZNN CM Asia without AS2 technique	ZNN CM Asia	Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.
ZNN CM Asia with AS2 technique	Open Reduction and Internal Fixation	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).
ZNN CM Asia with AS2 technique	ZNN CM Asia	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).
ZNN CM Asia with AS2 technique	Anterior Support Screw	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).
ZNN CM Asia without AS2 technique	Open Reduction and Internal Fixation	Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.

Primary Outcome Measures

Name	Time	Method
Number of Patient With and Without Excessive Lag Screw Sliding Distance	Postoperative 2-3 week	Number of patient was counted based on CT measurement results. Relative position of lag screw between CT images taken at both immediate and 2-3 weeks postoperatively was measured and recorded in value (e.g., 1.5 mm). This was called as "lag screw sliding distance". Four millimeter was set as threshold to define success and failure. Less than 4mm of lag screw sliding distance was recognized as Success and equal to or more than 4mm of lag screw sliding distance was recognized as Failure.

Secondary Outcome Measures

Name	Time	Method
Intraoperative Safety	Intraoperative	This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred.
Surgery Time	Intraoperative, an average of 1 hour	Surgery time from skin incision to closure
Image Assessment Using Computed Tomography (CT)	2-3 weeks postoperatively	Number of patient was counted based on CT measurement results. When the fracture reduction position achieved at surgery was maintained at 2 to 3 weeks, then the patient was categorized as success (Reduction position maintained). On the other hand, patient was categorized as failure (Reduction position changed) in the case that the fracture reduction position was changed. Fracture repair position was categorized into three; "Anterior", "Neutral" or "Posterior" based on relative position of proximal bone fragment and distal bone fragment. This analysis only includes patients whose fracture reduction position at immediate postoperative CT was either "Anterior" or "Neutral". If both immediate and 2-3 weeks postoperative CT images show same fracture reduction position (example: "Anterior" at immediate postoperatively \& "Anterior" at 2-3 weeks postoperatively), then the patient was recognized as Success (Reduction position maintained).

Locations (12): Kure Kyosai Hospital
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Kure, Hiroshima, Japan
Toyooka Hospital
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Toyooka, Hyogo, Japan
Kasugai Municipal Hospital
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Aichi, Kasugai, Japan
Hoshigaoka Medical Center
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Hirakata, Osaka, Japan
Numazu City Hospital
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Numazu, Shizuoka, Japan
Okayama Red Cross Hospital
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Okayama, Japan
Saiseikai Kumamoto Hospital
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Kumamoto, Japan
Saiseikai Takaoka Hospital
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Takaoka, Toyama, Japan
Kyushu Central Hospital
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Fukuoka, Japan
Niigata Central Hospital
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Niigata, Japan
Okayama Rosai Hospital
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Okayama, Japan
Saga Pref. Medical Centre Koseikan
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Saga, Japan