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CompletedNCT03673293Updated Nov 20, 2025

Measuring Postoperative Mobility, Gait Symmetry and Feedback Following TJA

An observational study in Total Joint Arthroplasty, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by University of Utah · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
58
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed 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 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.

02

Conditions studied

  • Total Joint Arthroplasty

Keywords

  • Total Joint Arthroplasty
  • Postoperative mobility
  • Gait symmetry
  • Feedback
03

In context

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who plan or recently underwent (up to 8 weeks postoperatively) primary total joint arthroplasty

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
58 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Peak Vertical Ground Reaction Forces (vGRF)

    Gait analysis of vertical ground reaction forces generated while performing routine exercises

    Time frame: 6-weeks

  2. Peak Vertical Ground Reaction Forces (vGRF)

    Gait analysis of vertical ground reaction forces generated while performing

    Time frame: 6-months

  3. Peak Vertical Ground Reaction Forces (vGRF)

    Gait analysis of vertical ground reaction forces generated while performing

    Time frame: 12-months

07

Study locations

1 site
  • University of Utah Orthopaedic Center
    Salt Lake City, Utah 84108, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03673293
Lead sponsor
University of Utah
Responsible party
Christopher Pelt (Principle Investigator, University of Utah) — Principal investigator
First posted
Sep 17, 2018
Start date
May 5, 2018
Primary completion
Aug 8, 2025
Completion
Aug 8, 2025
Last update
Nov 20, 2025

Study contacts

Christopher Pelt, MD
principal investigator · University of Utah

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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