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TracPatch Wearable Device for Knee Replacement Surgery Recovery

N/A
Waitlist Available
Led By Victor Hernandez
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Surgical candidate for total knee arthroplasty
Greater than 18 years of age
Must not have
Have previously undergone a TKA on that ipsilateral knee
Deformities of > 10 degrees valgus or varus or flexion contractures of > 10 degrees
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks after surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new wearable device that could improve patient outcomes after surgery by allowing patients and surgeons to monitor recovery in real time.

Who is the study for?
This trial is for adults over 18 who are about to have knee replacement surgery due to osteoarthritis and can consent. They must be able to use a smartphone with Bluetooth. It's not for those who've had the same surgery on that knee, have severe knee deformities, or complex cases as judged by their surgeon.
What is being tested?
The study tests the Consensus TracPatch, a wearable device tracking recovery after knee surgery using motion and temperature sensors. It aims to improve post-op mobility and patient-doctor communication by providing real-time data.
What are the potential side effects?
Since this trial involves a non-invasive monitoring device, there are no direct side effects like you'd expect from medication. However, skin irritation or an allergic reaction to the wearable's materials could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for a total knee replacement surgery.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a total knee replacement on the same knee before.
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My joint is bent or twisted more than 10 degrees.
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I am not fluent in English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Range of Motion
Secondary study objectives
Knee
Patient-Reported Outcome Measurement Information System (PROMIS)
Visual Analogue Score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Wearable Technology GroupExperimental Treatment1 Intervention
Patients in this arm will be provided with their own Consensus TracPatch wearable device postoperatively and instructed on its use for six weeks.
Group II: Current Standard of Care GroupActive Control1 Intervention
Patients in this arm will not be provided with any wearable device. Participants will be evaluated as part of the study for a total of six weeks.

Find a Location

Who is running the clinical trial?

Consensus OrthopedicsUNKNOWN
University of MiamiLead Sponsor
949 Previous Clinical Trials
428,307 Total Patients Enrolled
Victor HernandezPrincipal InvestigatorUniversity of Miami
~9 spots leftby Jun 2025
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