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

Phase 2

Recruiting

Conditions: Knee Osteoarthritis
Knee Osteoarthritis, Total Knee Arthroplasty
D020370

Registration Number: JPRN-jRCTs052230185

Lead Sponsor: Matsumoto Tomoyuki

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
[Efficacy endpoints]<br>Change in 2011 Knee Society Score (KSS) at 1 year postoperatively compared to the historical control<br>Hip-knee-ankle (HKA) angle at 3 months postoperatively (compared to historical control)<br>Intraoperative soft tissue balance<br>[safety endpoints]<br>Complications at 1 year postoperatively