TracPatch in Total Knee Arthroplasty

Study Overview
=================
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. 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 monitor patient recovery. This tool provides critical, real-time information that may offer a more complete source of data to understand a patient's postoperative clinical and rehabilitation course and guide physician postoperative management. The study hypothesizes that this new technology will improve patient postoperative mobility and patient-physician communication.

Official Title
-----------------
Evaluating the Efficacy of the TracPatch Wearable Technology on Patients Undergoing Total Knee Arthroplasty (TKA)

Conditions
-----------------
Arthroplasty, Replacement, Knee, Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Consensus TracPatch


Participation Criteria
=================
Eligibility 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: Unwilling or unable to provide consent Not fluent in the language of the informed consent form (English and Spanish) Prisoners Pregnant women Wards of the state Have previously undergone a TKA on that ipsilateral knee Deformities of > 10 degrees valgus or varus or flexion contractures of > 10 degrees. Considered by the surgeon to be a complex arthroplasty

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable Technology Group<br>Patients in this arm will be provided with their own Consensus TracPatch wearable device postoperatively and instructed on its use for six weeks. | Device: Consensus TracPatch<br>* 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.<br>|
| No Intervention: Current Standard of Care Group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Range of motion, including flexion and extension of the knee will be measured with a goniometer in degrees. Measured in degrees, the patients range of motion in the operative knee will be measured before surgery and continuously by the TracPatch monitor up to six weeks post-operatively. | Up to 6 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcome Measurement Information System (PROMIS) | The PROMIS is a 10-question survey that assesses patient's overall functional status and ability to accomplish activities of daily living. It has a total score ranging from 9-55 with 9 indicating poor functional status. | Up to 6 weeks after surgery | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.) | The KOOS Jr. is a standardized scoring system developed to rate both the knee prosthesis function and the patient's functional abilities after total knee arthroplasty. It has a total score ranging from 0-100 with 0 indicating more severe symptoms. | Up to 6 weeks after surgery | 
| Visual Analogue Score | A rating system from 1 - 10 developed to assess the patient's subjective rating of pain. A higher score indicates worse pain. | Up to 6 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wearable Technology, Total Knee Arthroplasty, Accelerometer