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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000036204
Receipt No. R000041243
Scientific Title Distal femur
Date of disclosure of the study information 2019/03/15
Last modified on 2019/04/26

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Basic information
Public title Distal femur
Acronym Distal femur
Scientific Title Distal femur
Scientific Title:Acronym Distal femur
Region
Asia(except Japan)

Condition
Condition Error in data collection
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Error in data collection and analysis, interpretation
Basic objectives2 Others
Basic objectives -Others Error in data collection and analysis, interpretation
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Error in data collection and analysis, interpretation
Key secondary outcomes Error in data collection and analysis, interpretation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Error in data collection and analysis, interpretation
Interventions/Control_2 Error in data collection and analysis, interpretation
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
95 years-old >=
Gender Male and Female
Key inclusion criteria Error in data collection and analysis, interpretation
Key exclusion criteria Error in data collection and analysis, interpretation
Target sample size 1

Research contact person
Name of lead principal investigator
1st name Rohan
Middle name A
Last name Bhimani
Organization Self
Division name Orthopedic Surgery
Zip code 400058
Address 8-bb, Lalubhai park, Mumbai
TEL 0918208768406
Email dr.rohanbhimani@gmail.com

Public contact
Name of contact person
1st name Rohan
Middle name A
Last name Bhimani
Organization Self
Division name Orthopedic Surgery
Zip code 400058
Address 8-bb, Lalubhai park
TEL 0918208768406
Homepage URL
Email dr.rohanbhimani@gmail.com

Sponsor
Institute Self,
8-bb, Lalubhai park, Mumbai
Institute
Department

Funding Source
Organization Rohan Bhimani
Self,
8-bb, Lalubhai park, Mumbai
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization India

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Self
Address 8-bb, Lalubhai larkmumbai - 400058
Tel +91 8208768406
Email fredbhimani@gmail.com

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 Self

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 15 Day

Related information
URL releasing protocol not yet published
Publication of results Unpublished

Result
URL related to results and publications not yet published
Number of participants that the trial has enrolled 1
Results
Error in the data analysis and interpretation.
Results date posted
2019 Year 03 Month 15 Day
Results Delayed
Delay expected
Results Delay Reason Error in data analysis and interpretation
Date of the first journal publication of results
2022 Year 06 Month 30 Day
Baseline Characteristics
Error in data analysis and interpretation 
Participant flow
Error in data analysis and interpretation 
Adverse events
None
Outcome measures
Distal femur
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Suspended
Date of protocol fixation
2016 Year 05 Month 15 Day
Date of IRB
2009 Year 06 Month 02 Day
Anticipated trial start date
2009 Year 08 Month 02 Day
Last follow-up date
2010 Year 07 Month 15 Day
Date of closure to data entry
2010 Year 08 Month 04 Day
Date trial data considered complete
2010 Year 08 Month 07 Day
Date analysis concluded
2010 Year 08 Month 07 Day

Other
Other related information Study has been terminated

Management information
Registered date
2019 Year 03 Month 15 Day
Last modified on
2019 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041243

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/04/22 Distal Fem.xlsx


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