UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021000
Receipt number R000024223
Scientific Title Patient satisfaction after surgical correction of hallux valgus: A prospective multicenter study.
Date of disclosure of the study information 2016/02/12
Last modified on 2020/09/28 21:39:40

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Basic information

Public title

Patient satisfaction after surgical correction of hallux valgus: A prospective multicenter study.

Acronym

Patient satisfaction after surgical correction of hallux valgus

Scientific Title

Patient satisfaction after surgical correction of hallux valgus: A prospective multicenter study.

Scientific Title:Acronym

Patient satisfaction after surgical correction of hallux valgus

Region

Japan


Condition

Condition

Hallux valgus

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify patient satisfaction after hallux valgus surgery and to clarify the factors related to patient satisfaction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Patient satisfaction after correction surgery for hallux valgus.

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 who are to undergo hallux valgus surgery.

Key exclusion criteria

Patients with hallux valgus deformity due to chronic inflammatory disease such as rheumatoid arthritis.
Patients undergoing midfoot and/or hindfoot surgery such as second tarsometatarsal joint arthrodesis and surgeries for flatfoot.
Patients who are judged as inappropriate for the study by the physicians in charge.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Tetsuro
Middle name
Last name Yasui

Organization

Teikyo University Mizonokuchi Hospital

Division name

Department of Orthopaedic Surgery

Zip code

2138507

Address

3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa

TEL

044-844-3333

Email

yasuit@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name Tetsuro
Middle name
Last name Yasui

Organization

Teikyo University Mizonokuchi Hospital

Division name

Department of Orthopaedic Surgery

Zip code

2138507

Address

3-8-3 Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa

TEL

044-844-3333

Homepage URL


Email

yasuit@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo University Mizonokuchi Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Chiba University, Kobe University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Teikyo University Ethical Review Board for Medical

Address

2-11-1 Kaga Itabashi Tokyo, Japan

Tel

0339647256

Email

yasuit@med.teikyo-u.ac.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

2016 Year 02 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

Enrolling by invitation

Date of protocol fixation

2016 Year 02 Month 12 Day

Date of IRB

2016 Year 05 Month 09 Day

Anticipated trial start date

2016 Year 05 Month 09 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

All the patients who visited the clinic and fulfilled the inclusion criteria after February 2016.


Management information

Registered date

2016 Year 02 Month 12 Day

Last modified on

2020 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024223


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name