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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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Utah Orthopaedic Center Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak Vertical Ground Reaction Forces (vGRF) Gait analysis of vertical ground reaction forces generated while performing routine exercises 6-weeks
Primary Peak Vertical Ground Reaction Forces (vGRF) Gait analysis of vertical ground reaction forces generated while performing 6-months
Primary Peak Vertical Ground Reaction Forces (vGRF) Gait analysis of vertical ground reaction forces generated while performing 12-months
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