臨床研究等提出・公開システム

Date of registration	April. 03, 2026
Last modified on	April. 03, 2026
Trial ID	jRCT1030260025

Scientific Title	Postoperative Clinical Outcome Study of high tibial osteotomy
Public Title	Postoperative Clinical Outcome Study of HTO

Contact for Scientific Queries	Name	Sato Masato
	Affiliation	Tokai Univercity
	Address	143 Shimokasuya, Isehara, Kanagawa, 259-1 193 Japan
	Telephone	+81-463-93-1121
	E-mail	sato-m@tokai.ac.jp
Contact for Public Queries	Name	Tsuchiya Izumi
	Affiliation	Tokai Univercity
	Address	143 Shimokasuya, Isehara, Kanagawa, 259-1 193 Japan
	Telephone	+81-463-93-1121
	E-mail	spring@tokai.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Aug. 10, 2017
Actual date of first enrollment		Dec. 06, 2017
Target sample size		40
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1.20 to 79 years of age at the time of giving consent 2.Patients eligible for HTO* 3.Written consent from the patient for the participation in the clinical study * Indication criteria for high tibial osteotomy(HTO) Osteoarthritis of the knee on the medial side Intact meniscus and cartilage on the lateral side No or slight osteoarthritis of the patellofemoral joint Femorotibial Angle (FTA) of equal or less than 185 degrees No knee flexion contracture No damage to knee ligaments
	Exclusion Criteria	1. Requires special ethical considerations 2. In cases where there are complications such as severe heart disease, respiratory disease, liver disease, or kidney disease 3.Women who are pregnant or lactating or are possibly pregnant 4.Other items that the principal investigator or co-investigator deems inappropriate
	Age Minimum	20age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Osteoarthritis of the knee
Primary Outcome(s)		Clinical evaluation of the Japanese Knee Injury and Osteoarthritis Outcome Score (JKOOS): Degree of improvement before HTO treatment and at 1 year after treatment
Secondary Outcome(s)		Various image evaluations, arthroscopic findings, clinical evaluation (Lysholm Knee Score)

Primary Sponsor	none

Name of Certified Review Board	Research Ethics Committee, Tokai University School of Medicine
Address	143 Shimokasuya, Isehara, Kanagawa, 259-1 193 Japan, Kanagawa
Telephone	+81-463-93-1121
E-Mail	tokai-rec@tokai.ac.jp
Approval Status	Approval
Date of approval	July. 10, 2017

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none