Measuring Postoperative Mobility, Gait Symmetry and Feedback Following TJA

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.

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Key information

Conditions

Total Joint Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Peak Vertical Ground Reaction Forces (vGRF)

Time frame: 6-weeks

Gait analysis of vertical ground reaction forces generated while performing routine exercises
Peak Vertical Ground Reaction Forces (vGRF)

Time frame: 6-months

Gait analysis of vertical ground reaction forces generated while performing
Peak Vertical Ground Reaction Forces (vGRF)

Time frame: 12-months

Gait analysis of vertical ground reaction forces generated while performing

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2025
Study completion: 2025
First posted: Sep 17, 2018
Registry last updated: Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed