UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008113
Receipt number R000009548
Scientific Title A multi-center, prospective study of Zimmer Natural Nail System GT Femoral Nails
Date of disclosure of the study information 2012/06/06
Last modified on 2016/09/07 11:22:47

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Basic information

Public title

A multi-center, prospective study of Zimmer Natural Nail System GT Femoral Nails

Acronym

ZINCS

Scientific Title

A multi-center, prospective study of Zimmer Natural Nail System GT Femoral Nails

Scientific Title:Acronym

ZINCS

Region

Japan


Condition

Condition

Primary femoral shaft fractures (AO 32-A1 to 32-C3)

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate anatomical fit of the nail for Asia to Mongoloid bone morphology and clinical outcomes

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

18 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1).Patient with primary femoral shaft (AO 32-A1 to 32-C3) fractures
2).Asia to Mongoloid patients only
3).Age (at the day of obtainment of consent): 18 to 75 years
4).Sex: Both males and females
5).Patient who is able to provide consent and sign the consent form
6).Patient is willing and able to complete scheduled follow-up evaluations as described in the informed consent
7).Patient who underwent acute and/or preoperative treatment such as Ex-Fix
8).Patient with independent walking ability before the fracture

Key exclusion criteria

1).Patient with obliteration of medullary canal due to a previous fracture or tumor
2).Patient with excessive bow or deformity at bone shaft
3).Patient with insufficient bone substance or bone quality
4).Patient with all concomitant diseases that can impair the functioning and the success of the implant
5).Patient with infection
6).Patient with insufficient blood circulation
7).Patient is skeletally immature
8).Patient who is suspected to have a metal allergy
9).Patient who is pregnant, suspected pregnancy or plan to get pregnant during the study observation period
10).Patient with pathologic fracture (including fracture caused by long-term treatment of Bisphosphonate)
11).Patient with periprosthetic fracture
12).Patient with history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
13).Patient who is under medication for Diabetes mellitus (DM) or with suspected DM, and whose HbA1c NGSP (National Glycohemoglobin Standardization Program) is equal or over than 6.5 % or JDS(Japan Diabetes Society) is equal or over than 6.1%
14).Patient with osseous metabolic diseases (excluding osteoporosis)
15).Patient with bilateral fracture or history of fracture at the other side on femur
16).Patient with any comorbidity (e.g. dementia, schizophrenia, depression, panic disorder or generalized anxiety disorder) which may affect the ability of informed consent or completion of assessments
17).Patient who will have to undergo THA, TKA or any operation of lower extremities within 6 months after enrollment
18).Patient who underwent THA, TKA or any operation of lower extremities within 6 months before enrollment

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

2-1-2 Asahicho, Takamatsu, Kagawa 760-8557, 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

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

TEL

03-6402-6773

Homepage URL


Email

akira.kashima@zimmerbiomet.com


Sponsor or person

Institute

Zimmer K.K.

Institute

Department

Personal name



Funding Source

Organization

Zimmer Biomet G.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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)、土浦協同病院(茨木県)、東京都立墨東病院(東京都)、新潟市民病院(新潟県)、石川県立中央病院(石川県)、小牧市民病院(愛知県)、岡山赤十字病院(岡山県)、香川労災病院(香川県)、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)、自治医科大学(栃木県)、富士市立中央病院(静岡県)、神戸市立医療センター中央市民病院(兵庫県)、那須赤十字病院(栃木県)、水戸中央病院(茨城県)、湘南鎌倉総合病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 06 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

2012 Year 05 Month 04 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 01 Day

Last follow-up date

2016 Year 01 Month 31 Day

Date of closure to data entry

2016 Year 09 Month 30 Day

Date trial data considered complete

2016 Year 09 Month 30 Day

Date analysis concluded

2016 Year 09 Month 30 Day


Other

Other related information

Multi-center, Prospective, Uncontrolled Clinical Study


Management information

Registered date

2012 Year 06 Month 06 Day

Last modified on

2016 Year 09 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009548


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name