TracPatch Wearable Device for Knee Replacement Surgery Recovery

Recruiting in Palo Alto (17 mi)

Overseen ByVictor H Hernandez, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Miami

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 who are about to have knee replacement surgery due to osteoarthritis and can consent. They must be able to use a smartphone with Bluetooth. It's not for those who've had the same surgery on that knee, have severe knee deformities, or complex cases as judged by their surgeon.

Inclusion Criteria

I am eligible for a total knee replacement surgery.

I am older than 18 years.

Exclusion Criteria

I have had a total knee replacement on the same knee before.

My joint is bent or twisted more than 10 degrees.

I am not fluent in English or Spanish.

Participant Groups

The study tests the Consensus TracPatch, a wearable device tracking recovery after knee surgery using motion and temperature sensors. It aims to improve post-op mobility and patient-doctor communication by providing real-time data.

2Treatment groups

Experimental Treatment

Active Control

Group I: Wearable Technology GroupExperimental Treatment1 Intervention

Patients in this arm will be provided with their own Consensus TracPatch wearable device postoperatively and instructed on its use for six weeks.

Group II: Current Standard of Care GroupActive Control1 Intervention

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.