UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014022
Receipt number R000016332
Scientific Title A Prospective, Multi-center Study of Zimmer Natural Nail System Cephalomedullary Asia Nail in Japanese Population
Date of disclosure of the study information 2014/05/26
Last modified on 2017/08/30 17:12:14

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Basic information

Public title

A Prospective, Multi-center Study of Zimmer Natural Nail System Cephalomedullary Asia Nail in Japanese Population

Acronym

ZiCAS

Scientific Title

A Prospective, Multi-center Study of Zimmer Natural Nail System Cephalomedullary Asia Nail in Japanese Population

Scientific Title:Acronym

ZiCAS

Region

Japan


Condition

Condition

Trochanteric fractures (AO 31-A1 to 31-A3)

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess anatomical fit of ZNN Cephalomedullary (CM) Asia Nail and clinical outcomes in patients who undertook CM Asia Nail

Basic objectives2

Others

Basic objectives -Others

Anatomical fit of the nail

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

CT Assessments

Key secondary outcomes

Radiographic Assessment, Clinical Assessments, and Safety Assessment


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Age of 50 years old or above.
2) Japanese patients (Mongoloid) only
3) Diagnosed with primary closed stable or unstable, intertrochanteric fractures of the femur.
4) Required or completed surgical intervention with CM Asia Nail.
5) Able to read and understand study information sheet, and decide to participate in the study by himself/ herself. Sign Patient Informed Consent Form either by patient own or his/ her representative.
6) Willing and capable of following the Investigator's instructions and complying with the follow-up visits.

Key exclusion criteria

1) A medullary canal obliterated by a previous fracture or tumor
2) Bone shaft having excessive bow or deformity
3) Lack of bone substance or bone quality which makes stable seating of the implant impossible
4) Concomitant diseases that can impair the functioning and the success of the implant
5) Infection
6) Insufficient blood circulation
7) Skeletally immature
8) Pregnant, suspected pregnancy or plan to get pregnant during the study observation period
9) Patients who cannot conduct CT scan examination within 3 days after the surgery
10) Patient with any comorbidities which may affect the ability of informed consent or completion of assessments

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Nagano

Organization

Kagawa Prefectural Central Hospital

Division name

Orthopaedic Surgery

Zip code


Address

1-2-1, Asahimachi, Takamatsu, Kagawa, Japan

TEL

087-811-3333

Email

chuobyoin@pref.kagawa.lg.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Kashima

Organization

Zimmer Biomet G.K.

Division name

Clinical Affairs

Zip code


Address

11-1, Shibakoen 2-chome, Minato-ku, Tokyo, Japan

TEL

03-6402-6610

Homepage URL


Email

akira.kashima@zimmerbiomet.com


Sponsor or person

Institute

Zimmer Biomet G.K.

Institute

Department

Personal name



Funding Source

Organization

Zimmer Biomet G.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

香川県立中央病院(香川県)、湘南鎌倉総合病院(神奈川県)、名古屋医療センター(愛知県)、浜脇整形外科病院(広島県)、佐賀県医療センター好生館(佐賀県)、熊本赤十字病院(熊本県)、香川労災病院(香川県)


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 26 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 05 Month 12 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 01 Day

Last follow-up date

2015 Year 05 Month 31 Day

Date of closure to data entry

2016 Year 01 Month 06 Day

Date trial data considered complete

2016 Year 01 Month 06 Day

Date analysis concluded

2016 Year 01 Month 06 Day


Other

Other related information

Demographic Info, Operative Info, X-ray/ CT Assessment, Clinical Assessment, Patient Outcome Measurement, Adverse Event Info


Management information

Registered date

2014 Year 05 Month 21 Day

Last modified on

2017 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016332


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name