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TracPatch in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03466476
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Consensus Orthopedics
Information provided by (Responsible Party):
Victor Hugo Hernandez, University of Miami

Tracking Information
First Submitted Date  ICMJE March 8, 2018
First Posted Date  ICMJE March 15, 2018
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE March 20, 2017
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
Range of Motion [ Time Frame: 6 weeks after surgery ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • Oxford Knee Score [ Time Frame: 6 weeks after surgery ]
    The Oxford Knee Score (OKS) is a 12-item patient reported outcome score designed to assess function and pain after total knee replacement
  • Knee Society Score [ Time Frame: 6 weeks after surgery ]
    The Knee Society Score is a standardized scoring system developed to rate both the knee prosthesis function and patient's functional abilities after total knee arthroplasty
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TracPatch in Total Knee Arthroplasty
Official Title  ICMJE Evaluating the Efficacy of the TracPatch Wearable Technology on Patients Undergoing Total Knee Arthroplasty
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.
Detailed Description

Total Knee Arthroplasty (TKA) has become a common operation that greatly improves patients' lives by restoring mobility. Studies show that the patient rehabilitation process is critical to final success of the operation.

The investigative device aids both the patient and the physician during rehabilitation by providing exercise feedback and providing the physician information about the patient's progress outside of the clinic.

Wearable devices for fitness tracking have become increasingly popular in the last few years. The Consensus TracPatch utilizes similar technology and methods in an effort to enhance the rehabilitation experience for both patients and physicians. Accelerometers are utilized to recognize and record the results when patients perform standard physical therapy exercises, in addition to providing standard step count and high-acceleration events that may indicate a fall. A temperature sensor monitors the skin temperature near the joint.

The device is attached by the patient to the shin approximately two inches below the knee through use of an adhesive strip similar to a standard bandage. The adhesive strip is disposable, allowing the device to be removed or relocated at any time.

Data is transferred from the TracPatch to the user's blue-tooth enabled iOS or Android device, which then syncs to an encrypted, HIPAA compliant, database in the cloud. The patient or physician may access the summarized data to track progress in flexion and extension exercises prescribed by the physician, monitor step counts and activity, and track temperature.

By having access to this data, a physician may:

  • Notice a particular patient is not making progress on their ROM goals, allowing for early intervention before a more invasive procedure is required;
  • Notice a particular patient is not performing their rehabilitation exercises, allowing for early intervention before a more invasive procedure is required;
  • Notice a particular patient is too active, allowing the surgeon to follow up with a patient to assess their activity level;
  • Notice a high acceleration event, allowing the surgeon to follow up with the patient to ensure their safety and the functionality of the implant;
  • Utilize the temperature trend information as a potential early indicator of periprosthetic infection, leading the surgeon to suggest further evaluation and intervention before the infection becomes more severe.

This product is an adaptation of products already commonly used throughout the world. It builds off the well-established technology to provide an aid to physicians and patients during the critical rehabilitation period. While it is not a diagnostic tool, it provides critical information that can help the physician use his or her professional expertise to get the patient mobile again and provide data relevant to post-surgical recovery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Arthroplasty, Replacement, Knee
  • Wearable Electronic Devices
Intervention  ICMJE Device: Consensus TracPatch
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.
Study Arms  ICMJE
  • Experimental: Wearable Technology
    Patients in this arm will be provided with their own Consensus TracPatch wearable device as well as instructions on its use.
    Intervention: Device: Consensus TracPatch
  • No Intervention: Current Standard
    Patients in this arm will not be provided with any wearable device.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Wayne B Cohen-Levy, MD 9544830206 wayne.cohenlevy@jhsmiami.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03466476
Other Study ID Numbers  ICMJE 20171099
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The researchers will share aggregate data but no individual's data will be shared. De-identified graphs of the accelerometer or range of motion output recordings from the devices may be used to illustrate the device's application.
Responsible Party Victor Hugo Hernandez, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Consensus Orthopedics
Investigators  ICMJE Not Provided
PRS Account University of Miami
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP