臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 20, 2024
Last modified on	Feb. 20, 2024
Trial ID	jRCTs052230185

Scientific Title	Prospective cohort clinical trial on the efficacy and safety of robotic-assisted devices (VELYS) for kinematically aligned total knee arthroplasty.
Public Title	Clinical study on efficacy and safety of VELYS for KA-TKA

Contact for Scientific Queries	Name	Matsumoto Tomoyuki
	Affiliation	Kobe University Hospital
	Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-382-5985
	E-mail	matsunt@med.kobe-u.ac.jp
Contact for Public Queries	Name	Tsubosaka Masanori
	Affiliation	Kobe University Hospital
	Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-382-5985
	E-mail	masanor1@med.kobe-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 20, 2024
Actual date of first enrollment
Target sample size		35
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. patients with end-stage (Kellgren-Lewrence classification Grade 3 or higher) knee osteoarthritis 2. patients aged 18 years or older, regardless of gender 3. patients scheduled to undergo total knee arthroplasty using the study device 4. patients who have given their free written consent to participate in this clinical study
	Exclusion Criteria	1. patients with inflammation of the knee joint (pyogenic arthritis, gout, pseudogout) 2. patients with active systemic infection requiring treatment 3. patients with diabetic peripheral neuropathy, spondylolisthesis, or spinal fistula 4. patients with externally deformed knees 5. patients with internally deformed knees more than 20 degrees 6. patients with flexion contracture knees more than 20 degrees 7. patients with post-traumatic deformity or osteoarthritis of the foot and ankle joints 8. patients who do not have sufficient bone density to support aleatory pins and implants 9. other patients deemed inappropriate by the investigators in charge of this clinical study
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Knee Osteoarthritis
Intervention(s)		Total knee arthroplasty with VELYS robotic-assisted system.
Health Condition(s) Keyword		Knee Osteoarthritis, Total Knee Arthroplasty
Intervention(s) Keyword		Total Knee Arthroplasty, Robotic-Assisted Surgery
Health Condition(s) Code		D020370
Intervention(s) Code		D065287
Primary Outcome(s)		Differences and outliers between component placement angles (femur and tibia) at preoperative planning and component placement angles (femur and tibia) at 3 months postoperative radiographs of the lower extremity (compared to historical control)
Secondary Outcome(s)		[Efficacy endpoints] Change in 2011 Knee Society Score (KSS) at 1 year postoperatively compared to the historical control Hip-knee-ankle (HKA) angle at 3 months postoperatively (compared to historical control) Intraoperative soft tissue balance [safety endpoints] Complications at 1 year postoperatively

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	Johnson & Johnson
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kobe University Clinical Research Ethical Committee
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan, Hyogo
Telephone	+81-78-382-6669
E-Mail	cerb@med.kobe-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 12, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none