UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035501
Receipt number R000039141
Scientific Title Associations between body measurements and knee symptoms in patients with knee osteoarthritis
Date of disclosure of the study information 2019/01/09
Last modified on 2022/07/13 19:56:17

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Basic information

Public title

Associations between body measurements and knee symptoms in patients with knee osteoarthritis

Acronym

Associations between body measurements and knee symptoms in patients with knee osteoarthritis

Scientific Title

Associations between body measurements and knee symptoms in patients with knee osteoarthritis

Scientific Title:Acronym

Associations between body measurements and knee symptoms in patients with knee osteoarthritis

Region

Japan


Condition

Condition

Knee Osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship between body measurement value and symptoms of knee osteoarthritis.

Basic objectives2

Others

Basic objectives -Others

Analysis of relationship

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pain rating scale of Japanese Knee Osteoarthritis Measure (JKOM-pain), Physical measurement value

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

50 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1 50 to 80 years old
2 Patients with degenerative knee osteoarthritis according to diagnostic criteria of the American College of Rheumatology
3 Patient with Kellgren Lawrence (K / L) classification 2 or higher in standing frontal knee joint X-ray image
4 Patients who gained document consent by the free will

Key exclusion criteria

1 Patients who received treatment such as exercise therapy, intra-articular injection and oral / external administration of anti-inflammatory analgesics at other medical institutions within 4 weeks of the survey.
2 Patient who is undergoing surgical treatment on the knee or planned
3 Patients with diseases requiring of steroid drugs
4 Damage of articular cartilage due to apparent trauma, arthritis, etc. Patients with a history
5 patients with diagnosis of rheumatoid arthritis, gout, pseudogout, collagen disease
6 Patients with severe cardiac dysfunction and liver / kidney function disorder
7 Other person who research director is inappropriate as the research subject

Target sample size

82


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukio Shimura

Organization

Minamikoshigaya Hospital

Division name

Department of Orthopeadic surgery

Zip code


Address

1-4-63 Minamikoshigaya, Koshigaya, Saitama

TEL

0489872811

Email

shimura@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukio Shimura

Organization

Minamikoshigaya Hospital

Division name

Department of Orthopeadic surgery

Zip code


Address

1-4-63 Minamikoshigaya, Koshigaya, Saitama

TEL

0489872811

Homepage URL


Email

shimura@juntendo.ac.jp


Sponsor or person

Institute

Minamikoshigaya Hospital

Institute

Department

Personal name



Funding Source

Organization

Minamikoshigaya Hospital

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

2019 Year 01 Month 09 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

2018 Year 09 Month 18 Day

Date of IRB

2018 Year 09 Month 18 Day

Anticipated trial start date

2018 Year 09 Month 21 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cross-sectional study


Management information

Registered date

2019 Year 01 Month 09 Day

Last modified on

2022 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039141


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name