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CM Asia Nail With AS2 Without AS2 (AS2 Study)

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ClinicalTrials.gov Identifier: NCT03196193
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment Phase
Trochanteric Fracture of Femur Procedure: Open Reduction and Internal Fixation Device: ZNN CM Asia Device: Anterior Support Screw Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: (Investigational group) or ZMM 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.
Primary Purpose: Treatment
Official Title: Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail With Anterior Support Screw (AS2) Versus Conventional Technique
Actual Study Start Date : March 21, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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 Name: 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.




Primary Outcome Measures :
  1. Effectiveness of AS2 technique: Maintenance rate of reduction position [ Time Frame: Postoperative 2-3 week ]
    The maintenance rate of reduction position at 2-3 weeks post-operatively


Secondary Outcome Measures :
  1. Surgery time [ Time Frame: Intraoperative ]
    Surgery time from skin incision to closure

  2. CT Assessment [ Time Frame: Immediate postoperative and 2-3 weeks ]
    Postoperative CT scanning to evaluate fracture reduction position.

  3. Safety Information: Any adverse events (including device related, non-device related, procedure related, non-procedure related) [ Time Frame: Intraoperative ]
    Any adverse events (including device related, non-device related, procedure related, non-procedure related)

  4. Safety Information: Any adverse events (including device related, non-device related, procedure related, non-procedure related) [ Time Frame: Up to 3 weeks (Up to 16 weeks (Option)) ]
    Any adverse events (including device related, non-device related, procedure related, non-procedure related)



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 classification (Nakano), and combination with a subtype P in lateral classification (Ikuta) at preoperative CT assessment.(In the case of classified in 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196193


Contacts
Contact: Yukako Nishino +81-3-6402-6771 yukako.nishino@zimmerbiomet.com
Contact: Takahito Nakai +81-3-6402-6777 takahito.nakai@zimmerbiomet.com

Locations
Japan
Kure Kyosai Hospital Recruiting
Kure, Hiroshima, Japan, 737-8505
Contact: Teramoto Hidefumi, MD    +81-823-22-2111    h-teramoto@kure-kyosai.jp   
Toyooka Hospital Recruiting
Toyooka, Hyogo, Japan, 668-8501
Contact: Mihara Kazushi, MD    +81-796-22-6111    gtttd898@yahoo.co.jp   
Kasugai Municipal Hospital Recruiting
Aichi, Kasugai, Japan, 486-8510
Contact: Hiroyuki Suzuki, MD    +81-568-57-0057    hiro_yuki_@yahoo.co.jp   
Hoshigaoka Medical Center Recruiting
Hirakata, Osaka, Japan, 573-8511
Contact: Okamoto Yasunori, MD    +81-72-840-2641    yasunori_0126@yahoo.co.jp   
Numazu City Hospital Recruiting
Numazu, Shizuoka, Japan, 410-0302
Contact: Mukouyama Shunsuke, MD, Ph. D    +81-55-924-5100    muko.524729@gmail.com   
Saiseikai Takaoka Hospital Recruiting
Takaoka, Toyama, Japan, 933-8525
Contact: Koichi Kanekasu, MD, Ph. D    +81-766-21-0570    knks@p1.tcnet.ne.jp   
Kyushu Central Hospital Recruiting
Fukuoka, Japan, 815-8588
Contact: Hamada Takahiro, MD    +81-92-541-4936    thamada@kyushu-ctr-hsp.com   
Saiseikai Kumamoto Hospital Recruiting
Kumamoto, Japan, 861-4193
Contact: Anraku Yoshihisa, MD, Ph. D    +81-96-351-8000    yoshihisa-anraku@saiseikaikumamoto.jp   
Niigata Central Hospital Recruiting
Niigata, Japan, 950-8556
Contact: Takashi Hayakawa, MD    +81-25-285-8811    hayakawa_tak_3322@hotmail.com   
Okayama Red Cross Hospital Recruiting
Okayama, Japan, 700-8607
Contact: Takeshi Doi, MD, Ph. D    +81-86-222-8811    orthopdoi@gmail.com   
Okayama Rosai Hospital Recruiting
Okayama, Japan, 702-8055
Contact: Masanori Yorimitsu, MD, Ph. D    +81-86-262-0131    mayorimitsu@minos.ocn.ne.jp   
Saga Pref. Medical Centre Koseikan Recruiting
Saga, Japan, 840-8571
Contact: Takao Mae, MD    +81-952-24-2171    maetakao@sannet.ne.jp   
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Takashi Maehara, MD, Ph. D Kagawa Rosai Hospital
  Study Documents (Full-Text)

Documents provided by Zimmer Biomet:

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03196193     History of Changes
Other Study ID Numbers: T.CR.I.AP.16.4
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries