Knee Osteoarthritis Knee Osteoarthritis, Total Knee Arthroplasty
Conditions
Interventions
Total knee arthroplasty with VELYS robotic-assisted system.
Total Knee Arthroplasty, Robotic-Assisted Surgery
Sponsors
Matsumoto Tomoyuki
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| [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 | — |
Contacts
Public ContactNakano Naoki
Kobe University Hospital
Outcome results
None listed