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临床试验/NCT06062615
NCT06062615已完成不适用

Randomized Pilot Study Investigating Early Functional Outcomes With the Use of Robotic Assisted Versus Conventional Total Knee Arthroplasty"

Rothman Institute Orthopaedics2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Early functional outcomes #2

研究概览

简要总结

As an intraoperative tool, a modern robotic total knee arthroplasty (TKA) system should be able to identify a patient's native femoral and tibial anatomy, as well as, assess ligament tension and gap balance. The surgeon in real time is then able to develop and execute a patient specific plan in terms of component size, alignment and rotation. In our institution we have begun to use, the OMNIBotics Knee system (Corin), which utilizes an active motorized knee spacer, BalanceBot, to objectively measure ligament tension and gap balance after the tibia has been cut and its alignment confirmed. This information is then processed through the OMNIbotics computer algorithm to appropriately size, align, and rotate the femur component to balance the flexion and extension gaps. The purpose of this study is to perform a randomized pilot study looking for an effect on early functional outcomes comparing robotic assisted TKA (RATKA) versus conventional TKA technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All unilateral primary knee arthroplasties performed by the investigator participating in this study will be eligible for inclusion
  • Diagnosis of primary osteoarthritis

排除标准

  • Revision surgery
  • Bilateral knee surgery
  • Age <18 or >80
  • Baseline lower extremity strength less than 5/5
  • History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
  • Functionally limiting spine disease
  • Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
  • Patients who cannot perform the baseline functional tests
  • Allergy/contraindication to protocol medications
  • Post-traumatic arthritis
  • Inflammatory arthritis
  • Pregnancy
  • Prisoners
  • Patients receiving care as a result of a worker's compensable injury
  • General anesthesia

结局指标

主要结局

Early functional outcomes #2

时间窗: 6 months

This will be measured by the stair climbing test.

early functional outcomes #1

时间窗: 6 months

This will be measured by the timed-up-and-go test.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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