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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196193
• Other study ID #: T.CR.I.AP.16.4
• Status: Completed
• Phase: N/A
• Start date: March 21, 2017
• Est. completion date: April 9, 2020

Study information

• Verified date: September 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 9, 2020
• Est. primary completion date: April 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Hip Fractures
• Trochanteric Fracture of Femur

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Kasugai Municipal Hospital	Aichi	Kasugai
Japan	Kyushu Central Hospital	Fukuoka
Japan	Hoshigaoka Medical Center	Hirakata	Osaka
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	Kure Kyosai Hospital	Kure	Hiroshima
Japan	Niigata Central Hospital	Niigata
Japan	Numazu City Hospital	Numazu	Shizuoka
Japan	Okayama Red Cross Hospital	Okayama
Japan	Okayama Rosai Hospital	Okayama
Japan	Saga Pref. Medical Centre Koseikan	Saga
Japan	Saiseikai Takaoka Hospital	Takaoka	Toyama
Japan	Toyooka Hospital	Toyooka	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patient With and Without Excessive Lag Screw Sliding Distance	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.	Postoperative 2-3 week
Secondary	Surgery Time	Surgery time from skin incision to closure	Intraoperative, an average of 1 hour
Secondary	Image Assessment Using Computed Tomography (CT)	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).	2-3 weeks postoperatively
Secondary	Intraoperative Safety	This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred.	Intraoperative