臨床研究等提出・公開システム

Scientific Title	Comparison of postoperative patient satisfaction using robot-assisted total knee arthroplasty with reference to knee alignment or ligament balance
Public Title	Comparison of postoperative patient satisfaction using robot-assisted TKA with reference to knee alignment or ligament balance

Contact for Scientific Queries	Name	Kuriyama Shinichi
	Affiliation	Kyoto Uneversity Hospital
	Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
	Telephone	+81-75-751-3366
	E-mail	seikei@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Kuriyama Shinichi
	Affiliation	Kyoto University Hospital
	Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
	Telephone	+81-75-751-3366
	E-mail	kuriyama@kuhp.kyoto-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 13, 2023
Actual date of first enrollment
Target sample size		204
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients undergoing total knee arthroplasty due to medial knee osteoarthritis. Patients with functioning collateral ligament of the knee. Adult male and female patients. Patients who are able to complete the questionnaire according to the study protocol.
	Exclusion Criteria	Patients with excessive varus or valgus deformity with advanced bone loss. Patients with medial and lateral collateral ligament dysfunction. Patients with inability to set robotic surgical references in the femoral and tibial shafts. Patients undergoing revision total knee arthroplasty. Patients with inflammatory diseases such as rheumatoid arthritis. Patients with allergies to implants and surgical instruments.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Medial knee osteoarthritis
Intervention(s)		Randomized Open-label Parallel-group comparison No controls
Health Condition(s) Keyword		knee osteoarthritis
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Comparison of 2011 knee society score at 2 years postoperatively between mechanical and kinematic alignment methods
Secondary Outcome(s)

Primary Sponsor	Kyoto University Hospital

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoecho, Sakyo-ku, Kyoto, Kyoto
Telephone	+81-75-753-4680
E-Mail	ethcom@kuhp.kyoto-u.ac.jp
Approval Status	Approval
Date of approval	Aug. 12, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none