UMIN-CTR Clinical Trial

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
Institute	Minamikoshigaya Hospital
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039141