UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036204
Receipt number R000041243
Scientific Title Distal femur
Date of disclosure of the study information 2019/03/15
Last modified on 2019/04/26 21:38:39

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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 or person

Institute

Self,
8-bb, Lalubhai park, Mumbai

Institute

Department

Personal name



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

Value
https://center6.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