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临床试验/NCT02717299
NCT02717299Unknown不适用

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

TriHealth Inc.2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
78
试验地点
2
主要终点
Patient Satisfaction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • 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.

排除标准

  • 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

结局指标

主要结局

Patient Satisfaction

时间窗: Surgery to 12 months post-operative

Overall Patient Satisfaction will be reported through various surveys.

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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