JPRN-jRCTs052230185RecruitingPhase 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 enrollmentStarted: February 20, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 35
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
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
Investigators
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