UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Variances of postoperative hospitalization days in patients with knee osteoarthritis undergoing arthroplasty; A multicenter study
Title of the study (Brief title)	Multicenter study in patients with undergoing knee arthroplasty
Region	Japan

Condition
Condition	knee osteoarthritis
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the variances of postoperative ospitalization days in patients with knee osteoarthritis undergoing arthroplasty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Number of postoperative hospitalization
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with undergoing total knee arthroplasty (TKA) 2.Patients with undergoing unicompartmental knee arthroplasty (UKA)
Key exclusion criteria	1.Patient with changing hospital or moving to the comprehensive rehabilitation ward 2.Patients with neurological symptoms problem 3.Patients with limited of movements by significant pain or limited range of motion impairment except the knee joint 4.Patients with dementia or psychiatric disease
Target sample size	500

Research contact person
Name of lead principal investigator	Tetsuya Amano
Organization	Tokoha University
Division name	Faculty of Health and Medical Sciences
Address	1230 miyakoda-cho, kita-ku, Hamamatsu-shi, Shizuoka-ken, Japan
TEL	053-428-1211
Email	tamano@hm.tokoha-u.ac.jp

Public contact
Name of contact person	Tetsuya Amano
Organization	Tokoha University
Division name	Faculty of Health and Medical Sciences
Address	1230 miyakoda-cho, kita-ku, Hamamatsu-shi, Shizuoka-ken,Japan
TEL	053-428-1211
Homepage URL	http://physical-therapy-diagnostics-group.kenkyuukai.jp/about/index.asp?
Email	tamano@hm.tokoha-u.ac.jp

Sponsor
Institute	Faculty of Health and Medical Sciences, Tokoha University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
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	2015 Year 01 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 17 Day
Anticipated trial start date	2013 Year 06 Month 21 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/jjrmc/53/9/53_723/_article/-char/ja/
Results
Other related information	Prospective cohort study

Management information
Registered date	2015 Year 01 Month 08 Day
Last modified on	2017 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018425