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临床试验/JPRN-jRCTs052230185
JPRN-jRCTs052230185招募中2 期

Prospective cohort clinical trial on the efficacy and safety of robotic-assisted devices (VELYS) for kinematically aligned total knee arthroplasty.

Matsumoto Tomoyuki0 个研究点目标入组 35 人开始时间: 2024年2月20日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
35

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 18age old 至 ot applicable(—)
性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Matsumoto Tomoyuki

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