UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A cohort study about therapeutic methods on osteoarthritis or rheumatoid arthritis of the knee
Title of the study (Brief title)	Moroyama knee cohort
Region	Japan

Condition
Condition	Osteoarthritis of the knee and rheumatoid arthritis of the knee
Classification by specialty	Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify limitation of conservative therapies, an indication of operative therapies, and the best type of operation by following-up the patients with osteoarthritis or rheumatoid arthritis of the knee
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of quality of life Limitation of conservative therapies
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with osteoarthritis or rheumatoid arthritis of the knee.
Key exclusion criteria	Iliterate persons Patients with sever complications
Target sample size	200

Research contact person
Name of lead principal investigator	Shinya Tanaka
Organization	Saitama medical university
Division name	Department of orthopaedic surgery
Address	Morohongo 38, Moroyama-cho, Iruma-gun
TEL	+81-49-276-1238
Email	tnk_sny@saitama-med.ac.jp

Public contact
Name of contact person	Shinya Tanaka
Organization	Saitama medical university
Division name	Department of orthopaedic surgery
Address	Morohongo 38, Moroyama-cho, Iruma-gun
TEL	+81-49-276-1238
Homepage URL
Email	tnk_sny@saitama-med.ac.jp

Sponsor
Institute	Saitama medical university
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 09 Month 05 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 24 Day
Anticipated trial start date	2013 Year 09 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The aim of this study is to clarify limtation of conservative theraphies, indication of operations, or the best type of operations by following-up patients with osteoarthritis or rheumatoid arthritis of the knee

Management information
Registered date	2013 Year 09 Month 02 Day
Last modified on	2018 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013601