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CM Asia Nail With AS2 Without AS2 （AS2 Study）

Primary Purpose

Trochanteric Fracture of Femur

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Open Reduction and Internal Fixation
ZNN CM Asia
Anterior Support Screw
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trochanteric Fracture of Femur

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kure Kyosai Hospital
  • Toyooka Hospital
  • Kasugai Municipal Hospital
  • Hoshigaoka Medical Center
  • Numazu City Hospital
  • Saiseikai Takaoka Hospital
  • Kyushu Central Hospital
  • Saiseikai Kumamoto Hospital
  • Niigata Central Hospital
  • Okayama Red Cross Hospital
  • Okayama Rosai Hospital
  • Saga Pref. Medical Centre Koseikan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ZNN CM Asia with AS2 technique

ZNN CM Asia without AS2 technique

Arm 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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgery Time
Surgery time from skin incision to closure
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).
Intraoperative Safety
This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred.

Full Information

First Posted
March 28, 2017
Last Updated
September 8, 2020
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT03196193
Brief Title
CM Asia Nail With AS2 Without AS2 （AS2 Study）
Official Title
Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail With Anterior Support Screw (AS2) Versus Conventional Technique
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 21, 2017 (Actual)
Primary Completion Date
April 2, 2020 (Actual)
Study Completion Date
April 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trochanteric Fracture of Femur

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
At surgery, intervention group using ZNN CM Asia with AS2 technique. At surgery, conventional group using ZNN CM Asia without AS2 technique.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
(Investigational group) or ZNN CM Asia without AS2 technique (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using a blocked randomization procedure. The block size will not be disclosed to the sites, and the doctor or other health care professional will not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZNN CM Asia with AS2 technique
Arm Type
Experimental
Arm 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).
Arm Title
ZNN CM Asia without AS2 technique
Arm Type
Active Comparator
Arm Description
Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation.
Intervention Type
Procedure
Intervention Name(s)
Open Reduction and Internal Fixation
Intervention Description
Fractured bone fragments are reduced and stabilized by intramedullary nail.
Intervention Type
Device
Intervention Name(s)
ZNN CM Asia
Intervention Description
Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.
Intervention Type
Device
Intervention Name(s)
Anterior Support Screw
Other Intervention Name(s)
ACE 4.5/5.0mm cannulated lag-screw
Intervention Description
Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.
Primary Outcome Measure Information:
Title
Number of Patient With and Without Excessive Lag Screw Sliding Distance
Description
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.
Time Frame
Postoperative 2-3 week
Secondary Outcome Measure Information:
Title
Surgery Time
Description
Surgery time from skin incision to closure
Time Frame
Intraoperative, an average of 1 hour
Title
Image Assessment Using Computed Tomography (CT)
Description
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).
Time Frame
2-3 weeks postoperatively
Title
Intraoperative Safety
Description
This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred.
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takashi Maehara, MD, Ph. D
Organizational Affiliation
Kagawa Rosai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kure Kyosai Hospital
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-8505
Country
Japan
Facility Name
Toyooka Hospital
City
Toyooka
State/Province
Hyogo
ZIP/Postal Code
668-8501
Country
Japan
Facility Name
Kasugai Municipal Hospital
City
Aichi
State/Province
Kasugai
ZIP/Postal Code
486-8510
Country
Japan
Facility Name
Hoshigaoka Medical Center
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-8511
Country
Japan
Facility Name
Numazu City Hospital
City
Numazu
State/Province
Shizuoka
ZIP/Postal Code
410-0302
Country
Japan
Facility Name
Saiseikai Takaoka Hospital
City
Takaoka
State/Province
Toyama
ZIP/Postal Code
933-8525
Country
Japan
Facility Name
Kyushu Central Hospital
City
Fukuoka
ZIP/Postal Code
815-8588
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
Niigata Central Hospital
City
Niigata
ZIP/Postal Code
950-8556
Country
Japan
Facility Name
Okayama Red Cross Hospital
City
Okayama
ZIP/Postal Code
700-8607
Country
Japan
Facility Name
Okayama Rosai Hospital
City
Okayama
ZIP/Postal Code
702-8055
Country
Japan
Facility Name
Saga Pref. Medical Centre Koseikan
City
Saga
ZIP/Postal Code
840-8571
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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CM Asia Nail With AS2 Without AS2 （AS2 Study）

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