臨床研究等提出・公開システム

Japanese

Date of registration	July. 20, 2024
Last modified on	July. 20, 2024
Trial ID	jRCT1050240094

Scientific Title	A study of the efficacy of patient education and early rehabilitation in total knee arthroplasty
Public Title	A study of the efficacy of patient education and early rehabilitation in total knee arthroplasty

Contact for Scientific Queries	Name	Tamaki Masashi
	Affiliation	Department of Orthopedics, Osaka University Graduate School of Medicine
	Address	2-2 Yamadaoka, Suita
	Telephone	+81-6-6879-3552
	E-mail	tamaki.masashi.x58@osaka-u.ac.jp
Contact for Public Queries	Name	Tamaki Masashi
	Affiliation	Department of Orthopedics, Osaka University Graduate School of Medicine
	Address	2-2 Yamadaoka, Suita
	Telephone	+81-6-6879-3552
	E-mail	tamaki.masashi.x58@osaka-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 20, 2024
Actual date of first enrollment
Target sample size		250
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-Initial total knee replacement surgery for osteoarthritis of the knee or femoral primary knee replacement surgery for osteoarthritis or femoral head -General medical care patient education app explained and app used -Patients who have been given a general medical explanation of the patient education app and have or who have decided voluntarily whether or not to use the app. -Patients who are able to and have the intention to complete the observation schedule described in the research implementation plan and who are willing to do so - Patients who provide written consent using the consent form approved by the ethics review committee
	Exclusion Criteria	-Simultaneous bilateral surgery cases -Patients with rheumatoid arthritis or post-traumatic osteoarthritis -Patients with neurological disorders such as hemiplegia and paraplegia -Patients who are unable to understand the explanation of participation in this study due to dementia or mental illness, or who are unable to follow the doctor's instructions in post-operative management -Patients who the principal investigator or sub-investigator deems to be unsuitable for the study
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Osteoarthritis and osteonecrosis
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code		D020370 & D010020
Intervention(s) Code
Primary Outcome(s)		Number of days after surgery until the patient meets the criteria for discharge from hospital
Secondary Outcome(s)		Correlation between the number of postoperative days until the achievement of discharge criteria and the patient-reported questionnaire at 12 months post-surgery (stratified analysis by number of days achieved: stratified analysis of the KOOS, KOOS Jr, and EQ-5D-5L patient-reported questionnaires at 3, 6, and 12 months post-surgery) Correlation between the number of times the patient education app is used and improvement in walking ability up to 12 months post-surgery Correlation between the type of artificial knee joint, surgical information, knee joint range of motion before and after surgery, rehabilitation information (number of times/number of units) and the patient-based questionnaire.

Primary Sponsor	none

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	IRB of Osaka University Hospital
Address	2 -2Yamadaoka, Osaka
Telephone	+81-6-6210-8270
E-Mail	handai-nintei@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	July. 12, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none