UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015629
Receipt number R000018161
Scientific Title Compensation of the foot for osteoarthritis of the knee
Date of disclosure of the study information 2014/11/12
Last modified on 2014/11/07 18:41:19

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Basic information

Public title

Compensation of the foot for osteoarthritis of the knee

Acronym

The foot in osteoarthritis of the knee

Scientific Title

Compensation of the foot for osteoarthritis of the knee

Scientific Title:Acronym

The foot in osteoarthritis of the knee

Region

Japan


Condition

Condition

Osteoarthritis of the knee

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clear the compensation of the foot for osteoarthritis of the knee.

Basic objectives2

Others

Basic objectives -Others

Biomechanics of the foot

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Radiographic measurement of the foot

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with knee osteoarthritis who have a plan of total knee replacement.

Key exclusion criteria

Patients who don't agree this reserch and cannot stand up.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasunori Suda

Organization

Keio University

Division name

Department of Orthopaedic Surgery

Zip code


Address

35, Shinanomachi, Shinjukuku-ku, Tokyo-to, Japan

TEL

03-3353-1211

Email

suda-y@a2.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeo Nagura

Organization

Keio University

Division name

Department of Orthopaedic Surgery

Zip code


Address

35, Shinanomachi, Shinjukuku-ku, Tokyo-to, Japan

TEL

03-3353-1211

Homepage URL


Email

nagura@z8.keio.jp


Sponsor or person

Institute

Department of Orthopaedic Surgery of Keio University

Institute

Department

Personal name



Funding Source

Organization

Department of Orthopaedic Surgery of Keio University

Organization

Division

Category of Funding Organization

Other

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

2014 Year 11 Month 12 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

2014 Year 09 Month 29 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 01 Day

Last follow-up date

2014 Year 11 Month 01 Day

Date of closure to data entry

2014 Year 11 Month 01 Day

Date trial data considered complete

2014 Year 11 Month 01 Day

Date analysis concluded

2014 Year 11 Month 01 Day


Other

Other related information

Radiographic measurement of the foot in osteoarthritis of the knee.


Management information

Registered date

2014 Year 11 Month 07 Day

Last modified on

2014 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018161


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name