CM Asia Nail With AS2 Without AS2 （AS2 Study）

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

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 Overview

• Status: Completed
• Conditions: Trochanteric Fracture of Femur
• Intervention / Treatment: Procedure: Open Reduction and Internal Fixation; Device: ZNN CM Asia; Device: Anterior Support Screw

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

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 815-8588
    • Kyushu Central Hospital
  • Kumamoto, Japan, 861-4193
    • Saiseikai Kumamoto Hospital
  • Niigata, Japan, 950-8556
    • Niigata Central Hospital
  • Okayama, Japan, 702-8055
    • Okayama Rosai Hospital
  • Okayama, Japan, 700-8607
    • Okayama Red Cross Hospital
  • Saga, Japan, 840-8571
    • Saga Pref. Medical Centre Koseikan
  • Hiroshima
    • Kure, Hiroshima, Japan, 737-8505
      • Kure Kyosai Hospital
  • Hyogo
    • Toyooka, Hyogo, Japan, 668-8501
      • Toyooka Hospital
  • Kasugai
    • Aichi, Kasugai, Japan, 486-8510
      • Kasugai Municipal Hospital
  • Osaka
    • Hirakata, Osaka, Japan, 573-8511
      • Hoshigaoka Medical Center
  • Shizuoka
    • Numazu, Shizuoka, Japan, 410-0302
      • Numazu City Hospital
  • Toyama
    • Takaoka, Toyama, Japan, 933-8525
      • Saiseikai Takaoka Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZNN CM Asia with AS2 technique; 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).	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.; Other Names: ACE 4.5/5.0mm cannulated lag-screw
Active Comparator: ZNN CM Asia without AS2 technique; Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery Time	Surgery time from skin incision to closure	Intraoperative, an average of 1 hour
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
Intraoperative Safety	This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred.	Intraoperative

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Takashi Maehara, MD, Ph. D, Kagawa Rosai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2017
• Primary Completion (Actual): April 2, 2020
• Study Completion (Actual): April 9, 2020

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Hip Fractures
• Other Study ID Numbers: T.CR.I.AP.16.4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes