Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03673293 |
Other study ID # |
110935 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 5, 2018 |
Est. completion date |
May 2025 |
Study information
Verified date |
August 2023 |
Source |
University of Utah |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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 loadsolĀ® (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.