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临床试验/NCT03673293
NCT03673293已完成不适用

Measuring Postoperative Mobility, Gait Symmetry and Feedback With New Technology Following Total Joint Arthroplasty

University of Utah1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2018年5月5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
58
试验地点
1
主要终点
Peak Vertical Ground Reaction Forces (vGRF)

研究概览

简要总结

The objectives of this study are:

  1. The investigators plan to evaluate and validate the use of a novel wireless insole device (Loadsol) that provides real-time biofeedback on post-operative mobility and weight bearing following total joint arthroplasty.
  2. The investigators plan to utilize the wireless insole device to determine if biofeedback is sufficient for improving gait symmetry following total joint arthroplasty.
  3. The investigators plan to determine if there is a correlation between patient reported outcomes and measured postoperative weight bearing.

详细描述

In orthopaedic and trauma surgery post-operative mobility is very important. Six-month mortality and patient satisfaction has been associated with mobility. Elderly patients may suffer from severe complications caused by immobility due to a high prevalence of comorbidities.

Measuring postoperative mobility has primarily been based on advanced technology and complicated gait laboratories (treadmill, force plate, videoanalysis). The recent introduction of mobile insole force devices, such as the pedoped loadsol® (Novel) may allow for a cost-effective and clinically relevant use of providing biofeedback.

Using video analysis to evaluate the insole device will allow for measurements in realistic situations like walking stairs, stand up from a chair, sit down, turning and walking. The investigators had previously completed this in the lab setting and further the feedback mode of the loadsol will be used for training the patients in terms of symmetry after a total knee replacement.

This study may have an important influence on the aftercare of the investigators patients. Determining the postoperative mobility and evaluating gait analysis in real time will allow the investigators to compare between different operative approaches, operative techniques, Implants and more. If the feedback mode is working as expected the investigators might use it in the close future in the investigators standard aftercare for all patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Planned or recently underwent (up to 8 weeks postoperatively) primary total joint arthroplasty
  • Free walking before surgery, no devices needed
  • Age >/=18 years
  • Preoperative outcomes scores (PF CAT, PROMIS Global Health, KOOS JR)
  • Written informed consent

排除标准

  • Index procedure is a revision total joint arthroplasty
  • Total knee or hip arthroplasty on the contralateral side within 1 one year of index procedure
  • Severe medical comorbidity (ASA>/=3)
  • Participant is planning TJA on another joint within next 12 months
  • Significant symptoms on contralateral knee/hip/ankle that could impede performance on study

结局指标

主要结局

Peak Vertical Ground Reaction Forces (vGRF)

时间窗: 12-months

Gait analysis of vertical ground reaction forces generated while performing

次要结局

未报告次要终点

研究者

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

Christopher Pelt

Principle Investigator

University of Utah

研究点 (1)

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