UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040542
Receipt number R000046279
Scientific Title Comparison of postoperative patient satisfaction with WOMAC in THA and TKA patients
Date of disclosure of the study information 2020/05/27
Last modified on 2020/05/27 14:34:56

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Basic information

Public title

Comparison of postoperative patient satisfaction with WOMAC in THA and TKA patients

Acronym

Comparison of postoperative patient satisfaction with WOMAC in THA and TKA patients

Scientific Title

Comparison of postoperative patient satisfaction with WOMAC in THA and TKA patients

Scientific Title:Acronym

Comparison of postoperative patient satisfaction with WOMAC in THA and TKA patients

Region

Japan


Condition

Condition

Osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of postoperative patient satisfaction with WOMAC in THA and TKA patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

WOMAC score, patient satisfaction

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

30 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

THA or TKA for osteoarthritis

Key exclusion criteria

history of surgeries of the knee or hip

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kentaro
Middle name
Last name Iwakiri

Organization

Shiraniwa Hospital

Division name

Department of Orthopaedic Surgery

Zip code

6300136

Address

6-10-1 Shiraniwadai Ikoma-city Nara

TEL

0743-70-0022

Email

kenpiecekenpiece@yahoo.co.jp


Public contact

Name of contact person

1st name Kentaro
Middle name
Last name Iwakiri

Organization

Shiraniwa Hospital

Division name

Department of Orthopaedic Surgery

Zip code

6300136

Address

6-10-1 Shiraniwadai Ikoma-city Nara

TEL

0743-70-0022

Homepage URL


Email

kenpiecekenpiece@yahoo.co.jp


Sponsor or person

Institute

Shiraniwa Hospital

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiraniwa Hospital

Address

6-10-1 Shiraniwadai Ikoma-city Nara

Tel

0743-70-0022

Email

kenpiecekenpiece@yahoo.co.jp


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

2020 Year 05 Month 27 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

Suspended

Date of protocol fixation

2012 Year 05 Month 01 Day

Date of IRB

2012 Year 04 Month 28 Day

Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date

2020 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Comparison of postoperative patient satisfaction with WOMAC in THA and TKA patients


Management information

Registered date

2020 Year 05 Month 27 Day

Last modified on

2020 Year 05 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046279


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name