TracPatch in Total Knee Arthroplasty

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.

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