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临床试验/NCT03052790
NCT03052790撤回不适用

Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)

研究概览

简要总结

The purpose of this study is to compare the outcomes and accuracy of implant positioning in robotic assisted total knee arthroplasty with traditional manually instrumented total knee arthroplasty.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have knee pain and are candidates for total knee arthroplasty
  • Patients able to consent to be included in the study

排除标准

  • Patients with previous total or partial knee arthroplasty in need of revision surgery
  • Patients unable to or unwilling to undergo post-operative CT scans after understanding the risks and benefits

研究组 & 干预措施

manually instrumented total knee arthroplasty

Active Comparator

Manually instrumented implantation of a total knee prosthesis involves use of cutting guides or jigs that are secured to the femur and the tibia. The femoral guide is secured to the femur after an intramedullary referenced guide is placed into the femur and the rotational alignment is then assessed with use of the epicondylar axis. An extra-medullary tibial alignment guide will be used to create the tibial cut.

干预措施: manually instrumented total knee arthroplasty (Procedure)

robotic assisted total knee arthroplasty

Experimental

Robotically assisted surgery is used in conjunction with the preoperative CT scan and intra-operative bony registration of the patient's knee. Femoral and tibial trackers are placed and then the bone is registered using bony landmarks to allow the computer and robot to know where the patients' femur and tibia are in space. Once this is complete the preoperative templated surgical plan (performed by the PI) is used to register where to make the bony cuts in order to implant the knee components. The cutting process is performed by the surgeon with the robot assisting in guiding the cuts based on the registered CT anatomy. The surgeon has complete control of the cutting process with the assistance of the robot for placement of the cuts.

干预措施: robotic assisted total knee arthroplasty (Device)

结局指标

主要结局

Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)

时间窗: within 2 weeks before surgery, within one month of surgery

The absolute value of the individual differences in various angle measurements will be added together to form a total summation of angle difference.

次要结局

  • Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system(1 year after surgery)
  • Pain as assessed by a Visual Analogue Scale (VAS)(1 year after surgery)
  • Function as assessed by the PROMIS 10 measurement system(1 year after surgery)
  • Pain as assessed by the PROMIS 10 measurement system(1 year after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam M Freedhand

Assistant Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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