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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019328
Receipt No. R000022347
Scientific Title Japanese outcomes in neck fracture
Date of disclosure of the study information 2015/10/13
Last modified on 2016/09/12

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Basic information
Public title Japanese outcomes in neck fracture
Acronym JOIN
Scientific Title Japanese outcomes in neck fracture
Scientific Title:Acronym JOIN
Region
Japan

Condition
Condition Femoral neck fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the outcomes, indication, and clinical questions on BHA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative outcomes(3 years)
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients are candidate for BHA.
2) Patients have diagnosis of Femoral Neck Fracture.
3) Patients are age 20 or over.
4) Patients, who agree on an IRB-approved, study specific Informed Patient Consent Form
5) Patients are willing and able to comply with postoperative scheduled evaluations.
Key exclusion criteria Patients have bacterial infectious disease or have risk highly of bacterial infection.
2) Patients are lower ADL, that is using wheelchair and bedridden.
3) Patients have a severe bone deformity by rheumatism or osteotomy.
4) Patients who is pregnant female or maybe so.
5) Patients who are judged ineligible with reasonable reason by primary doctor.
Target sample size 1400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Jinno
Organization Tokyo Medical Dental University
Division name Orthopaedic
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510
TEL 03-3813-6111
Email jinno.ort@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenta Suzuki
Organization Stryker Japan K.K.
Division name Clinical Affairs
Zip code
Address 2-6-1 Koraku, Bunkyo-ku, Tokyo 112-0004
TEL 03-6894-8357
Homepage URL
Email kenta.suzuki@stryker.com

Sponsor
Institute Stryker Japan K.K.
Institute
Department

Funding Source
Organization Stryker Japan K.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

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 13 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 Enrolling by invitation
Date of protocol fixation
2015 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Radiographic evaluation
Functional score
Patient's satisfaction

Management information
Registered date
2015 Year 10 Month 13 Day
Last modified on
2016 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022347

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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