JPRN-jRCTs052230185
Recruiting
Phase 2
Prospective cohort clinical trial on the efficacy and safety of robotic-assisted devices (VELYS) for kinematically aligned total knee arthroplasty.
Matsumoto Tomoyuki0 sites35 target enrollmentFebruary 20, 2024
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Matsumoto Tomoyuki
- Enrollment
- 35
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Not specified
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