UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of preoperative pain, physical function factors, and psychological factors on postoperative physical activity for total knee arthroplasty
Title of the study (Brief title)	Preoperative factors influencing postoperative activity after knee arthroplasty
Region	Japan

Condition
Condition	total knee arthroplasty
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate the influence of preoperative pain, physical function factors, and psychological factors on postoperative physical activity levels.
Basic objectives2	Others
Basic objectives -Others	Apply to clinical management early postoperatively.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	daily step count
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	60 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The study included patients who underwent TKA for osteoarthritis from April 2014 to June 2018 in the medical institution to which the first author belongs.
Key exclusion criteria	Exclusion criteria were as follows: an inability to understand the objectives of the study due to dementia, mental health disorders, postoperative complications such as nerve injury or deep vein thrombosis, other significant medical diseases which interfered with postoperative rehabilitation, previous TKA (TKA of the opposite limb and revision), and TKA performed for causes other than degenerative diseases (rheumatoid arthritis and bone necrosis).
Target sample size	180

Research contact person
Name of lead principal investigator	Yuki Hiraga
Organization	Fukuoka Rehabilitation Hospital
Division name	Rehabilitation
Address	770-7, Nokata, Fukuoka Nishi-ku Fukuoka
TEL	0928121555
Email	nokopata_nokopata@yahoo.co.jp

Public contact
Name of contact person	Yuki Hiraga
Organization	Fukuoka Rehabilitation Hospital
Division name	Rehabilitation
Address	770-7, Nokata, Fukuoka Nishi-ku Fukuoka
TEL	0928121555
Homepage URL
Email	nokopata_nokopata@yahoo.co.jp

Sponsor
Institute	Fukuoka Rehabilitation Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2018 Year 12 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 01 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	During the research, four participants withdrew, and 139 participants completed the study.

Management information
Registered date	2018 Year 12 Month 11 Day
Last modified on	2018 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040133