Measuring Postoperative Mobility, Gait Symmetry and Feedback Following TJA

NCT03673293 | Completed DMC

• 1 other identifier: 110935
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are:

1. 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. 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. 3.The investigators plan to determine if there is a correlation between patient reported outcomes and measured postoperative weight bearing.

Conditions

Total Joint Arthroplasty

Keywords

Total Joint Arthroplasty; Postoperative mobility; Gait symmetry; Feedback

Outcome Measures

Primary Outcomes (3)

• Peak Vertical Ground Reaction Forces (vGRF)

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

  6-weeks

• Peak Vertical Ground Reaction Forces (vGRF)

  Gait analysis of vertical ground reaction forces generated while performing

  6-months

• Peak Vertical Ground Reaction Forces (vGRF)

  Gait analysis of vertical ground reaction forces generated while performing

  12-months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Study Officials

• Christopher Pelt, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 17, 2018
• Study Start: May 5, 2018
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

US (1)