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TracPatch in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03466476
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : May 27, 2022
Sponsor:
Collaborator:
Consensus Orthopedics
Information provided by (Responsible Party):
Victor Hugo Hernandez, University of Miami

Brief Summary:
Total Knee Arthroplasty is becoming an increasingly common operation. An important part of a successful overall patient outcome is regaining functional range of motion after surgery. Wearable devices for fitness have become increasingly common in the general population. This study seeks to utilize wearable technology to enhance the post-operative rehabilitation experience by allowing patients and surgeons to monitor patient recovery in real time. The Consensus TracPatch is a wearable device which utilizes an accelerometer, temperature sensor and step count to allow the surgeon and patient to monitor recovery and help ensure critical milestones are being met. Our hypothesis is that this new technology will improve patient outcomes as it pertains to rehabilitation milestones and overall satisfaction as compared to controls who do not utilize this technology.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Wearable Electronic Devices Device: Consensus TracPatch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients who meet enrollment criteria will be randomized to either the treatment group where they will receive their consensus tracpatch or be assigned to the control group where no wearable technology will be employed.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of the TracPatch Wearable Technology on Patients Undergoing Total Knee Arthroplasty
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Wearable Technology
Patients in this arm will be provided with their own Consensus TracPatch wearable device as well as instructions on its use.
Device: Consensus TracPatch

Consensus TracPatch will be attached to the participant's shin approximately two inches below the knee through use of an adhesive strip similar to a standard bandage for 6 weeks after total knee arthroplasty.

The information gained by the TracPatch wearable technology will be readily available via a HIPAA secure system to the surgeon and patient in order to monitor post-operative recovery and signal to both parties if any intervention is indicated. The device also monitors for rapid acceleration events which may indicate a traumatic injury. Additionally, the temperature sensor may help detect sub-clinical infection.


No Intervention: Current Standard
Patients in this arm will not be provided with any wearable device.



Primary Outcome Measures :
  1. Range of Motion [ Time Frame: 6 weeks after surgery ]

    Flexion and extension of the knee will be measured with a goniometer in degrees, the sum of which will determine range of motion.

    Measured in degrees, the patients range of motion in the operative knee will be measured before surgery, at the 2-week post operative visit and the 6-week post operative visit.



Secondary Outcome Measures :
  1. Oxford Knee Score [ Time Frame: 6 weeks after surgery ]
    The Oxford Knee Score (OKS) with a total range of 0- 48 with a lower score indicating more severe symptoms. OKS is a 12-item patient reported outcome score designed to assess function and pain after total knee replacement.

  2. Knee Society Score (KSS) [ Time Frame: 6 weeks after surgery ]
    The Knee Society Score is a standardized scoring system developed to rate both the knee prosthesis function and the patient's functional abilities after total knee arthroplasty. The KSS has a total score ranging from 0-100 with 0 indicating more severe symptoms.

  3. Visual Analogue Score [ Time Frame: 6 weeks after surgery ]
    A rating system from 1 - 10 developed to assess the patient's subjective rating of pain. A higher score indicates worse pain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgical candidate for total knee arthroplasty
  • Greater than 18 years of age
  • Have signed the written informed consent form
  • Have consistent access to an iOS or Android device with Bluetooth capability

Exclusion Criteria:

  • Patients not fluent in the language of the informed consent form
  • Prisoners
  • Pregnancy
  • Reported to have mental illness or belonging to a vulnerable population
  • Have previously undergone a TKA on that same knee
  • Deformities of more than 10 degrees on either valgus or varus or flexion contractures of more than 10 degrees.
  • Considered by the surgeon to be complex arthroplasty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466476


Contacts
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Contact: Victor B Hernandez, MD 3056895195 vhh1@med.miami.edu

Locations
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United States, Florida
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Victor H Hernandez, MD    305-689-5195    vhh1@med.miami.edu   
Principal Investigator: Victor H Hernandez, MD         
Sub-Investigator: Matthew Lavelle, MD         
Sub-Investigator: Michele D'Apuzzo, MD         
Sub-Investigator: Sagie Haziza         
Sponsors and Collaborators
University of Miami
Consensus Orthopedics
Investigators
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Principal Investigator: Victor Hernandez University of Miami
Additional Information:
Publications:
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Responsible Party: Victor Hugo Hernandez, Assistant Professor, Arthroplasty & Joint Reconstruction, University of Miami
ClinicalTrials.gov Identifier: NCT03466476    
Other Study ID Numbers: 20171099
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Victor Hugo Hernandez, University of Miami:
Wearable Technology
Total Knee Arthroplasty