TracPatch in Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03466476|
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Knee Wearable Electronic Devices||Device: Consensus TracPatch||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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)|
|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 :||April 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
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
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.
- 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.
- 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.
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
|Contact: Wayne B Cohen-Levy, MDfirstname.lastname@example.org|
|United States, Florida|
|University of Miami Hospital||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Wayne B Cohen-Levy, MD 954-483-0206 email@example.com|
|Contact: Spencer H Summers, MD 5612137406 firstname.lastname@example.org|
|Principal Investigator: Victor H Hernandez, MD|
|Sub-Investigator: Wayne B Cohen-Levy, MD|
|Sub-Investigator: Matthew Lavelle, MD|
|Sub-Investigator: Dinorah Rodriguez, RN|
|Sub-Investigator: Aaron Hoyt, BS|
|Sub-Investigator: Karina Galoian, PhD|