Total Joint ArthroplastyNCT03673293
Measuring Postoperative Mobility, Gait Symmetry and Feedback Following TJA
An observational study of Total Joint Arthroplasty, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Joint Arthroplasty
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2018to 8 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who plan or recently underwent (up to 8 weeks postoperatively) primary total joint arthroplasty
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Measuring Postoperative Mobility, Gait Symmetry and Feedback With New Technology Following Total Joint Arthroplasty
The objectives of this study are:
- 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.
- The investigators plan to utilize the wireless insole device to determine if biofeedback is sufficient for improving gait symmetry following total joint arthroplasty.
- 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.
- Conditions
- Total Joint Arthroplasty
- Keywords
- Total Joint Arthroplasty, Postoperative mobility, Gait symmetry, Feedback
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Vertical Ground Reaction Forces (vGRF)
Gait analysis of vertical ground reaction forces generated while performing routine exercises
Measured: 6-weeks
Peak Vertical Ground Reaction Forces (vGRF)
Gait analysis of vertical ground reaction forces generated while performing
Measured: 6-months
Peak Vertical Ground Reaction Forces (vGRF)
Gait analysis of vertical ground reaction forces generated while performing
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start5 May 2018
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Joint ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Pelt, University of Utah
- Investigators
- Christopher Pelt, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673293
- Sponsor's protocol ID
- 110935
- Status last verified
- Nov 2025
- First submitted
- 12 Sep 2018
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Postoperative Mobility, Gait Symmetry and Feedback With New Technology Following Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT03673293
- Acronym / sponsor ID
- 110935
- Conditions
- Total Joint Arthroplasty
- Keywords
- Total Joint Arthroplasty, Postoperative mobility, Gait symmetry, Feedback
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 5 May 2018 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are:
- 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.
- The investigators plan to utilize the wireless insole device to determine if biofeedback is sufficient for improving gait symmetry following total joint arthroplasty.
- The investigators plan to determine if there is a correlation between patient reported outcomes and measured postoperative weight bearing.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who plan or recently underwent (up to 8 weeks postoperatively) primary total joint arthroplasty
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Pelt, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Joint Arthroplasty, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Vertical Ground Reaction Forces (vGRF) (time frame: 6-weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.