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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008113
Receipt No. 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

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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
Institute Zimmer K.K.
Institute
Department

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
URL(English) https://upload.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


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