Clinical study on efficacy and safety of VELYS for KA-TKA

JRCT ID: jRCTs052230185

Registered date:20/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Knee Osteoarthritis
• Date of first enrollment: 20/02/2024
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Total knee arthroplasty with VELYS robotic-assisted system.

Outcome(s)

• Primary Outcome: 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

[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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Matsumoto Tomoyuki
• Source(s) of Monetary Support: Johnson & Johnson