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Making Sense Out of Total Knee Sensor Assisted Technology: A Randomized Control Trial

2020年4月30日 更新者:TriHealth Inc.
The purpose of this study is to compare the patient reported outcome measures of total knee replacement patients who received intra operative sensor guided technique for soft tissue balancing to a group of patients who receive surgeon guided soft tissue balancing.

研究概览

详细说明

This study will compare a group of total knee arthroplasty patients who receive sensor guidance technology for soft tissue balancing intra operatively to a group of patients who receive surgeon guided soft tissue balancing. Patients will be randomized to either the experimental group with the sensor guided technology or the control group which is the surgeon guided technique and current standard of care. All patients will have the sensor placed intra operatively so that measurements can be captured and recorded however, the measurements for the patients who are not in the sensor guided group will not be revealed to the surgeon. The information will be gathered for post enrollment data analysis only. The patients measurements in the sensor guided group will be revealed to the surgeon and the surgeon will use this information in order to help guide soft tissue balancing for optimal alignment intra operatively. Patients will be followed for 1 year post operatively. Patient reported outcomes measures such as KSS, KOOS, PROMIS PF CAT, EQ-5D and UCLA activity will be collected preoperatively and at 3 months, 6 months, and 12 months. Post-operative Likert scale patient satisfaction scores will also be collected. All outcomes will be scored and compared to determine significance.

研究类型

介入性

注册 (预期的)

78

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Cincinnati、Ohio、美国、45220
        • Good Samarian Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients undergoing primary unilateral total knee arthroplasty for osteoarthritis, avascular necrosis, inflammatory arthropathy, or post traumatic arthritis.
  • Patients able to understand study intent, and agree to study participation.
  • Patients receiving Smith and Nephew Journey II total knee implant system.

Exclusion Criteria:

  • Patients with previous ipsilateral knee ligament surgery.
  • Patients with orthopaedic and medical co-morbidities that would thwart postoperative recovery such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy, ipsilateral hip disease), severe knee deformity.
  • Untreated Osteoarthritis
  • BMI > 40
  • ASA class > III
  • History of drug or alcohol abuse

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Sensor Guided Tissue Balancing
Patients in this group will have the Verasense trial sensor device inserted, and the data collected electronically. The surgeon will use this data to intraoperatively align the knee according to the indications of the data.
Verasense will collect balancing data on all patients in this trial.
安慰剂比较:Surgeon Guided Tissue Balancing
Patients in this group will have the Verasense trial sensor device inserted, and the data collected electronically. The computer displaying the data will be turned away from the surgeon, so that he is not able to use the sensor data, and must balance the knee with feel and visual estimation of balance.
Verasense will collect balancing data on all patients in this trial.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Patient Satisfaction
大体时间:Surgery to 12 months post-operative
Overall Patient Satisfaction will be reported through various surveys.
Surgery to 12 months post-operative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Mark Snyder, MD、TriHealth Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年11月1日

初级完成 (实际的)

2019年4月1日

研究完成 (预期的)

2021年4月8日

研究注册日期

首次提交

2016年3月15日

首先提交符合 QC 标准的

2016年3月22日

首次发布 (估计)

2016年3月23日

研究记录更新

最后更新发布 (实际的)

2020年5月4日

上次提交的符合 QC 标准的更新

2020年4月30日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 15-053

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Yes, Orthosensor receives the data collected.

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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