How does it work?
Your device is activated and operated using the Synotrac app on your smartphone. Simply hold your bluetooth enabled device close to your leg, and activate the device. The app will take the measurements, and securely store them in your phone. Your surgeon will also have access to this data, allowing them the ability to track your healing progress over time.
How are measurements processed?
Measurements are processed in the Synotrac app, sent to your physician, and automatically plotted and compared with other measurements taken.
What are the benefits?
Synotrac protects you by detecting infection before it is too late to save your implant. Bacteria colonizing the implant will form a biofilm, a protective layer that cements the presence of bacteria in the joint environment and renders antibiotic treatment ineffective. Once a biofilm has formed and matured, an expensive revision surgery is required, which drastically reduces quality of life. By notifying you and your physician of the presence of infection early, Synotrac offers a solution that puts postoperative care in your hands.
What are the risks?
The risks associated with Synotrac are standard to any implantable device. With the introduction of a foreign object into the body, there is risk of infection during installation, allergic reaction to components, and bruising or swelling at the site of installation. Synotrac adheres to all FDA requirements for limiting these risks.
What are the alternatives?
There is currently no technology on the market which serves to noninvasively and proactively detect infection after joint replacement surgery. Ordinarily, follow up testing for infection and other adverse effects is only performed months after surgery, or if you develop symptoms. If these tests discover an infection, it will only be after a biofilm has formed and a revision surgery will be required.
Where does the device go?
Synotrac sits adjacent to the synovial cavity of the joint on a non-articulating surface of the prosthesis and minimally protrudes into the synovium, ensuring accurate measurements and seamless integration into the implant. In other words, it sits on the side of the implant where it can best measure infection without interfering with the normal functions of the prosthesis.
Does the device come out?
No, Synotrac is made entirely from biocompatible components and is sealed with protective coating to ensure that it can remain inside the body for the entire lifespan of the implant.
How is the device installed?
The device is installed intraoperatively–during joint replacement–so no additional surgery is required for installation or operation of the device.
How invasive is the device?
Once Synotrac is implanted, it is operated wirelessly to take quicks measurements. Measurements are taken noninvasively to protect you from any unnecessary exposure to postoperative infection.
How long does it work for?
The device’s batteries will last for the initial postoperative period when you are at highest risk for infection: up to 6 months post surgery. In the future, your phone will charge the device as it is taking measurements, so it will work indefinitely.
How long should I be worried about infection?
Infection introduced intraoperatively generally presents within the first two to three months post surgery, often within the first month.
What happens if I do have an infection?
If you have an infection, Synotrac will notify you and your physician in time to treat it early. Your doctor will determine the exact course of action, but prompt treatment dramatically improves patient outcomes.
What type of patient should have this implanted?
Synotrac is designed to protect anyone who gets a joint replacement from requiring revision surgery. Patients at high risk for infection, particularly those who have developed one previously, are highly encouraged to use this technology to be especially vigilant.
How will this affect my frequency of post-op visits?
Synotrac monitors the joint environment, and provides snapshots over time to create a dynamic picture of healing progress. This data is securely sent to your surgeon, allowing them to access and monitor individual progress wirelessly. The Synotrac app communicates with you and your physician to minimize the need for postoperative appointments. In the event that an infection is suspected, your doctor will bring you in for confirmatory testing and treatment.
How will it affect my quality of life?
Synotrac is designed to improve your quality of life by notifying you and your surgeon of the presence of infection early. This can save your implant, and prevent the permanent physical and steep financial consequences of a revision surgery, allowing you to resume your life and normal activities faster, and fully enjoy the benefits of your new joint!
Will the device set off a metal detector?
Over 90% of total joint replacements will set off a metal detector. Synotrac will not add any sensitivity to triggering a metal detector.
Can I go in the water?
Yes! As soon as your doctor approves you to resume normal activity, anything you can do with your new joint you can do with Synotrac!